Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT03416127
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2018-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011429', 'term': 'Propolis'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D012116', 'term': 'Resins, Plant'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uiec@prodigy.net.mx', 'phone': '+52 3310585200', 'title': 'DR. MANUEL GONZALEZ ORTIZ', 'phoneExt': '34212', 'organization': 'INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Throughout the study, an average of 12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Serum Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'PRIMARY', 'title': '2 Hours After Oral Glucose Tolerance Test in Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.963', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': '2-h serum glucose levels were evaluated at week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'PRIMARY', 'title': 'Glycosylated Hemoglobin (A1C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.236', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12', 'unitOfMeasure': '% of A1C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Total Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.\n\nPeriod Title: Overall Study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Total insulin secretion was calculated at week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12.\n\nThe insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.\n\nPeriod Title: Overall Study'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "Insulin sensitivity was calculated at week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12.\n\nMatsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity", 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'First Phase of Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1346', 'spread': '784', 'groupId': 'OG000'}, {'value': '996', 'spread': '742', 'groupId': 'OG001'}, {'value': '1652', 'spread': '863', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.162', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The first phase of insulin secretion was calculated at week 12 with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12.\n\nHuman studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion", 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'AUC Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '921', 'spread': '126', 'groupId': 'OG000'}, {'value': '967', 'spread': '116', 'groupId': 'OG001'}, {'value': '939', 'spread': '126.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.686', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Area under the curve (AUC) of glucose was calculated with the polygonal formula.\n\nThe area under the curve (AUC) of glucose, (0.5 \\* glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 \\* G 120´) \\* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia.', 'unitOfMeasure': 'mmol*min/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'AUC Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '44123', 'spread': '13381', 'groupId': 'OG000'}, {'value': '27603', 'spread': '15935', 'groupId': 'OG001'}, {'value': '51287', 'spread': '7440', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Area under the curve (AUC) of insulin was calculated with the polygonal formula.\n\nThe area under the curve (AUC) of insulin, (0.5 \\* Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 \\* I 120´) \\* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia.', 'unitOfMeasure': 'pmol*min/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '12.0', 'spread': '1.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.945', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.332', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '14.9', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.075', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.7', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '102.2', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '101.5', 'spread': '10.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.903', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Waist circumference was evaluated at week 12 with a flexible tape', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '81.0', 'spread': '15.2', 'groupId': 'OG001'}, {'value': '77.8', 'spread': '13.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.697', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '30.0', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.668', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Body Mas Index was calculated at week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Percentage of Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '33.6', 'spread': '8.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.308', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Percentage of fat mass was evaluated through bioimpedance.', 'unitOfMeasure': '% of fat mass', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.318', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.880', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'High Density Lipoprotein Cholesterol (c-HDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.376', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Low Density Lipoproteins Cholesterol (c-LDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.210', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Very Low Density Lipoprotein (c-VLDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.880', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '63.6', 'spread': '26.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '339.0', 'spread': '77.3', 'groupId': 'OG000'}, {'value': '327.1', 'spread': '71.4', 'groupId': 'OG001'}, {'value': '333.1', 'spread': '95.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.978', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '114.6', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '119.2', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '112.8', 'spread': '6.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.122', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The systolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.8', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '74.4', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '72.3', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.551', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'The diastolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'FG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.\n\nPropolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'BG001', 'title': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.\n\nMetformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.\n\nPlacebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '7', 'groupId': 'BG000'}, {'value': '51', 'spread': '4', 'groupId': 'BG001'}, {'value': '50', 'spread': '5', 'groupId': 'BG002'}, {'value': '49', 'spread': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fasting serum glucose', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '1.2', 'groupId': 'BG002'}, {'value': '7.7', 'spread': '1.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Fasting serum glucose was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2 hours after OGTT', 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '15.8', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '13.2', 'spread': '1.9', 'groupId': 'BG002'}, {'value': '14.5', 'spread': '2.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '2-h serum glucose was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin (A1C)', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '6.8', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '6.7', 'spread': '0.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Glycosylated Hemoglobin (A1C) was evaluated with liquid chromatography method.', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.4', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'BG002'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion', 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin sensitivity', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'BG002'}, {'value': '1.0', 'spread': '0.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity", 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'First phase of insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '2092', 'spread': '653', 'groupId': 'BG000'}, {'value': '1608', 'spread': '736', 'groupId': 'BG001'}, {'value': '2221', 'spread': '566', 'groupId': 'BG002'}, {'value': '1984', 'spread': '686', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion", 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AUC glucose', 'classes': [{'categories': [{'measurements': [{'value': '965', 'spread': '137', 'groupId': 'BG000'}, {'value': '1039', 'spread': '174', 'groupId': 'BG001'}, {'value': '930', 'spread': '90', 'groupId': 'BG002'}, {'value': '978', 'spread': '133.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.', 'unitOfMeasure': 'mmol*min/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AUC insulin', 'classes': [{'categories': [{'measurements': [{'value': '52541', 'spread': '9165', 'groupId': 'BG000'}, {'value': '45323', 'spread': '9005', 'groupId': 'BG001'}, {'value': '53869', 'spread': '5053', 'groupId': 'BG002'}, {'value': '50577.6', 'spread': '7741', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.', 'unitOfMeasure': 'pmol*min/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose 30 min after oral glucose tolerance test', 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '13.7', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '12.0', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '12.7', 'spread': '2.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Glucose 30' was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose 60 min after oral glucose tolerance test', 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '17.2', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '14.7', 'spread': '1.9', 'groupId': 'BG002'}, {'value': '15.6', 'spread': '2.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Glucose 60' was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose 90 min after oral glucose tolerance test', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '17.5', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '2.8', 'groupId': 'BG002'}, {'value': '15.5', 'spread': '2.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Glucose 90' was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '101.2', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '103.4', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '103.2', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '102.6', 'spread': '10.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '76.4', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '80.7', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '78.6', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '78.6', 'spread': '12.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '30.2', 'spread': '3.13', 'groupId': 'BG002'}, {'value': '29.5', 'spread': '3.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index was calculated as weight (kg) divided by height (m2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percentage of fat mass', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '33.8', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '32.4', 'spread': '8.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Percentage of fat mass was evaluated through bioimpedance.', 'unitOfMeasure': '% fat mass', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '4.8', 'spread': '0.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Total cholesterol was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '2.0', 'spread': '1.0', 'groupId': 'BG002'}, {'value': '2.0', 'spread': '0.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Triglycerides were analyzed with the triglycerides oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Density Lipoprotein cholesterol (c-HDL)', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '0.9', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'BG002'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'High-density lipoprotein cholesterol (c-HDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low-Density Lipoproteins-cholesterol (c-LDL)', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '3.0', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '2.9', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '3.0', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Low-density lipoprotein-cholesterol (c-LDL) was calculated with the Friedewald formula as follows: LDL-c (mmol/L)= TC (mmol/L) - HDL-c (mmol/L) - \\[TG(mmol/L)/2.2\\]', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Very low density lipoprotein (VLDL)', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '0.9', 'spread': '0.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Very low density cholesterol (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '31.8', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '21.2', 'groupId': 'BG001'}, {'value': '69.8', 'spread': '27.4', 'groupId': 'BG002'}, {'value': '70.7', 'spread': '26.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Creatinine was analyzed with the alkaline picrate technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Uric acid', 'classes': [{'categories': [{'measurements': [{'value': '356.9', 'spread': '71.4', 'groupId': 'BG000'}, {'value': '315.2', 'spread': '65.4', 'groupId': 'BG001'}, {'value': '309.2', 'spread': '89.2', 'groupId': 'BG002'}, {'value': '327.1', 'spread': '77.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Uric acid was analyzed with the uric acid oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '116.9', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '118.4', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '115.7', 'spread': '7.2', 'groupId': 'BG002'}, {'value': '117.0', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '76.2', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '73.4', 'spread': '6.7', 'groupId': 'BG002'}, {'value': '75.4', 'spread': '7.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-06', 'size': 205191, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-16T20:57', 'hasProtocol': True}, {'date': '2017-04-06', 'size': 192635, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-16T20:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2018-01-23', 'resultsFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-16', 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Serum Glucose', 'timeFrame': 'Week 12', 'description': 'The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12'}, {'measure': '2 Hours After Oral Glucose Tolerance Test in Week 12', 'timeFrame': 'Week 12', 'description': '2-h serum glucose levels were evaluated at week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12'}, {'measure': 'Glycosylated Hemoglobin (A1C)', 'timeFrame': 'Week 12', 'description': 'Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12'}], 'secondaryOutcomes': [{'measure': 'Total Insulin Secretion', 'timeFrame': 'Week 12', 'description': 'Total insulin secretion was calculated at week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12.\n\nThe insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion'}, {'measure': 'Insulin Sensitivity', 'timeFrame': 'Week 12', 'description': "Insulin sensitivity was calculated at week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12.\n\nMatsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity"}, {'measure': 'First Phase of Insulin Secretion', 'timeFrame': 'Week 12', 'description': "The first phase of insulin secretion was calculated at week 12 with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12.\n\nHuman studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion"}, {'measure': 'AUC Glucose', 'timeFrame': 'Week 12', 'description': 'Area under the curve (AUC) of glucose was calculated with the polygonal formula.\n\nThe area under the curve (AUC) of glucose, (0.5 \\* glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 \\* G 120´) \\* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia.'}, {'measure': 'AUC Insulin', 'timeFrame': 'Week 12', 'description': 'Area under the curve (AUC) of insulin was calculated with the polygonal formula.\n\nThe area under the curve (AUC) of insulin, (0.5 \\* Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 \\* I 120´) \\* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia.'}, {'measure': 'Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week', 'timeFrame': 'Week 12', 'description': "The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12"}, {'measure': 'Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week', 'timeFrame': 'Week 12', 'description': "The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12"}, {'measure': 'Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week', 'timeFrame': 'Week 12', 'description': "The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12."}, {'measure': 'Waist Circumference', 'timeFrame': 'Week 12', 'description': 'Waist circumference was evaluated at week 12 with a flexible tape'}, {'measure': 'Body Weight', 'timeFrame': 'Week 12', 'description': 'The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12'}, {'measure': 'Body Mass Index', 'timeFrame': 'Week 12', 'description': 'Body Mas Index was calculated at week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12'}, {'measure': 'Percentage of Fat Mass', 'timeFrame': 'Week 12', 'description': 'Percentage of fat mass was evaluated through bioimpedance.'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Week 12', 'description': 'Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12'}, {'measure': 'Triglycerides', 'timeFrame': 'Week 12', 'description': 'Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12'}, {'measure': 'High Density Lipoprotein Cholesterol (c-HDL)', 'timeFrame': 'Week 12', 'description': 'c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12'}, {'measure': 'Low Density Lipoproteins Cholesterol (c-LDL)', 'timeFrame': 'Week 12', 'description': 'c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12'}, {'measure': 'Very Low Density Lipoprotein (c-VLDL)', 'timeFrame': 'Week 12', 'description': 'Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.'}, {'measure': 'Creatinine', 'timeFrame': 'Week 12', 'description': 'Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques'}, {'measure': 'Uric Acid', 'timeFrame': 'Week 12', 'description': 'Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Week 12', 'description': 'The systolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Week 12', 'description': 'The diastolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus type 2', 'Glycemic control', 'Propolis', 'Metformin', 'Pharmacological treatment-naïve patients'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of propolis or metformin on glycemic control in patients with type 2 diabetes mellitus without pharmacological treatment.\n\nAll patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index, and Matsuda index were measured.', 'detailedDescription': 'A randomized, double-blind, placebo-controlled clinical trial of three pharmacological groups was carried out, with the participation of 36 patients with type 2 Diabetes Mellitus without pharmacological treatment.\n\nAt the beginning and end of the study, fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, and a metabolic profile were measured. Areas under the curve of glucose and insulin, total insulin secretion insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated.\n\nAll patients received for 12 weeks two capsules a day, one before the first bite of breakfast and another before the first bite of dinner. 12 of them took propolis (300 mg), another 12 received metformin (850 mg), and 12 more placebo in the same pharmacological presentation.\n\nThis protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.\n\nResults are presented as mean and standard deviation. Intra-group differences were evaluated using Kruskal-Wallis and Mann-Whitney U-tests, while inter-group differences were calculated with the Wilcoxon test; p≤0.05 was considered significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients both sexes\n* Age between 30 and 60 years\n* Mild to moderate physical activity\n* Stable body weight for at least 12 weeks prior to the study\n* BMI 25.0 - 34.9 kg/m2\n* Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels \\>126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose \\>200 mg/dl\n* Informed consent signed\n\nExclusion Criteria:\n\n* Women with confirmed or suspected pregnancy\n* Women under lactation and/or puerperium\n* Previous treatment for glucose\n* Fasting glucose ≥250 mg/dL\n* Known uncontrolled renal, hepatic, heart or thyroid diseased\n* Hypersensibility to ingredients of intervention\n* Known allergies to bee stings or their derived products\n* Triglycerides ≥500 mg/dL\n* Total cholesterol ≥240 mg/dL'}, 'identificationModule': {'nctId': 'NCT03416127', 'briefTitle': 'Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment', 'orgStudyIdInfo': {'id': 'PROPOLIS-METFORMIN-DM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propolis', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.', 'interventionNames': ['Drug: Propolis']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules, two times per day before break-fast and dinner during 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Propolis', 'type': 'DRUG', 'description': 'Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.', 'armGroupLabels': ['Propolis']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Metformin hydrochloride'], 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Calcined magnesium'], 'description': 'Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'MANUEL GONZALEZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intstituto de Terapeútica Experimental y Clínica.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher Professor', 'investigatorFullName': 'Manuel González Ortiz', 'investigatorAffiliation': 'University of Guadalajara'}}}}