Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT02708966
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2016-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075206', 'term': 'Gurmarin protein, Gymnema sylvestre'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esperanzamartnezabundi@yahoo.com', 'phone': '+52-33-10-58-52-00', 'title': 'Dra. Esperanza Martínez Abundis', 'phoneExt': '34211', 'organization': 'Institute of Experimental and Clinical Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the 90 days of the study', 'eventGroups': [{'id': 'EG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Abdominal distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Anorexy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Sweet taste intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Polydipsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ANY'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '77.4', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).'}, {'type': 'PRIMARY', 'title': '2-hour Post Load Plasma Glucose (2-h PG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Glycated Hemoglobin A1c (A1C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention by high-performance liquid chromatography', 'unitOfMeasure': 'Percent of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Insulin Secretion (Insulinogenic Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.', 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'First Phase of Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '1399', 'spread': '552', 'groupId': 'OG000'}, {'value': '1528', 'spread': '677', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': "First 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') after intervention.", 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Insulin Sensitivity (Matsuda Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': "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)\\] after intervention.", 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve of Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '1075', 'spread': '253', 'groupId': 'OG000'}, {'value': '1018', 'spread': '158', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Area under the curve of glucose was obtained using the trapezoidal integration.', 'unitOfMeasure': 'mmol/l/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '56968', 'spread': '20787', 'groupId': 'OG000'}, {'value': '53374', 'spread': '20663', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention area under the curve of insulin', 'unitOfMeasure': 'mmol/l/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Weight (BW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '77.4', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '29.3', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Waist Circumference (WC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '99', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'spread': '15', 'groupId': 'OG000'}, {'value': '120', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '10', 'groupId': 'OG000'}, {'value': '77', 'spread': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'High Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Low Density Lipoprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Very Low Density Lipoprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'classes': [{'categories': [{'measurements': [{'value': '70.8', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '70.8', 'spread': '17.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with impaired glucose tolerance (IGT)\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gymnema Sylvestre', 'description': 'Patients with IGT\n\nGymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients with IGT\n\nPlacebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '10', 'groupId': 'BG000'}, {'value': '44', 'spread': '7', 'groupId': 'BG001'}, {'value': '45', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight (BW)', 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '79.1', 'spread': '16.8', 'groupId': 'BG001'}, {'value': '79.3', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '30.4', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference (WC)', 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '98.8', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '98', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WC was evaluated after an overnight fast 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': 'Systolic blood pressure (SBP)', 'classes': [{'categories': [{'measurements': [{'value': '117', 'spread': '12', 'groupId': 'BG000'}, {'value': '119', 'spread': '12', 'groupId': 'BG001'}, {'value': '118', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SBP 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 SBP. The value was expressed on mmHg.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure (DBP)', 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '13', 'groupId': 'BG000'}, {'value': '77', 'spread': '8', 'groupId': 'BG001'}, {'value': '77', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The DBP 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 DBP. The value was expressed on mmHg.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides (TGs)', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol (TC)', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'high-density lipoprotein cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.9', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low-density lipoprotein cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Very-low density lipoprotein (VLDL)', 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '0.3', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5 . The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '5.6', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-hour postload plasma glucose (2-h PG)', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '8.6', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycated hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '5.6', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent of glycated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '79.5', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '70.8', 'spread': '26.5', 'groupId': 'BG001'}, {'value': '70.8', 'spread': '17.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Area under the curve of glucose (AUCG)', 'classes': [{'categories': [{'measurements': [{'value': '1157', 'spread': '147', 'groupId': 'BG000'}, {'value': '1078', 'spread': '137', 'groupId': 'BG001'}, {'value': '1120', 'spread': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.', 'unitOfMeasure': 'mmol/L/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Area under the curve of insulin (AUCI)', 'classes': [{'categories': [{'measurements': [{'value': '68,348', 'spread': '20,329', 'groupId': 'BG000'}, {'value': '63,544', 'spread': '28,041', 'groupId': 'BG001'}, {'value': '65946', 'spread': '24188', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.', 'unitOfMeasure': 'pmol/L/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'spread': '0.20', 'groupId': 'BG000'}, {'value': '0.54', 'spread': '0.22', 'groupId': 'BG001'}, {'value': '0.54', 'spread': '0.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose).', 'unitOfMeasure': 'unitless', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'First phase of insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '1297', 'spread': '550', 'groupId': 'BG000'}, {'value': '1391', 'spread': '712', 'groupId': 'BG001'}, {'value': '1344', 'spread': '627', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "First 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').", 'unitOfMeasure': 'unitless', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin sensitivity', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "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)\\].", 'unitOfMeasure': 'unitless', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-18', 'size': 597940, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-11-12T21:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2016-03-10', 'resultsFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2016-03-10', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-12', 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Plasma Glucose', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry'}, {'measure': '2-hour Post Load Plasma Glucose (2-h PG)', 'timeFrame': '90 days', 'description': 'The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.'}, {'measure': 'Glycated Hemoglobin A1c (A1C)', 'timeFrame': '90 days', 'description': 'After intervention by high-performance liquid chromatography'}, {'measure': 'Total Insulin Secretion (Insulinogenic Index)', 'timeFrame': '90 days', 'description': 'Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.'}, {'measure': 'First Phase of Insulin Secretion', 'timeFrame': '90 days', 'description': "First 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') after intervention."}, {'measure': 'Insulin Sensitivity (Matsuda Index)', 'timeFrame': '90 days', 'description': "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)\\] after intervention."}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve of Glucose', 'timeFrame': '90 days', 'description': 'Area under the curve of glucose was obtained using the trapezoidal integration.'}, {'measure': 'Area Under the Curve of Insulin', 'timeFrame': '90 days', 'description': 'After intervention area under the curve of insulin'}, {'measure': 'Body Weight (BW)', 'timeFrame': '12 weeks', 'description': 'The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '12 weeks', 'description': 'The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12'}, {'measure': 'Waist Circumference (WC)', 'timeFrame': '12 weeks', 'description': 'Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12'}, {'measure': 'Systolic Blood Pressure (SBP)', 'timeFrame': '12 weeks', 'description': 'The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12'}, {'measure': 'Diastolic Blood Pressure (DBP)', 'timeFrame': '12 weeks', 'description': 'The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12'}, {'measure': 'Total Cholesterol', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry'}, {'measure': 'Triglycerides', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry'}, {'measure': 'High Density Lipoprotein Cholesterol', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry'}, {'measure': 'Low Density Lipoprotein', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry'}, {'measure': 'Very Low Density Lipoprotein', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry'}, {'measure': 'Creatinine', 'timeFrame': '90 days', 'description': 'After intervention by spectrophotometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gymnema Sylvestre', 'Glycemic control'], 'conditions': ['Impaired Glucose Tolerance']}, 'descriptionModule': {'briefSummary': 'Prediabetes (PD) was defined as an state in which glucose levels are above normal but not enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with IGT, it is expected that by 2035 this number will increase to 417 million people affected. Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including: increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose utilization in various ways and inhibition of glucose uptake in the intestine.', 'detailedDescription': 'The target is to evaluate the effect of the administration of Gymnema Sylvestre on glycemic control, insulin secretion and insulin sensibility on patients with IGT. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 female and male patients, between 30 and 59 years old with IGT (2-h values in the oral glucose tolerance test, OGTT) from 140 mg / dL to 199 mg / dL), Body Mass Index (BMI) from 25 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 9-week trial (Gymnema Sylvestre capsules, 300 mg 2 times daily with the first bite of breakfast and dinner or homologated placebo capsules). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at week 9. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p \\<0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI: 25.0-34.99 kg / m2.\n* Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)\n* Written informed consent.\n* body weight stable over the last 3 months.\n* Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.\n* Women who are not contemplated get pregnant within the next 6 months.\n\nExclusion Criteria:\n\n* Women pregnant or breastfeeding.\n* Physical or mental disability that makes it impossible to perform the intervention.\n* Diagnosis of hypertension or heart failure.\n* Smokers.\n* Untreated thyroid disease.\n* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).\n* Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.\n* Diagnosis of renal disease or creatinine \\> 1.5 mg / dl.\n* Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.\n* Total Cholesterol ≥ 280 mg/dL.\n* Triglycerides ≥ 300 mg/dL.\n* Known allergy to calcined magnesia or Gymnema sylvestre.'}, 'identificationModule': {'nctId': 'NCT02708966', 'briefTitle': 'Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.', 'orgStudyIdInfo': {'id': 'GSIG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gymnema Sylvestre', 'description': 'Patients with IGT', 'interventionNames': ['Drug: Gymnema Sylvestre']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients with IGT', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gymnema Sylvestre', 'type': 'DRUG', 'otherNames': ['Gurmar'], 'description': 'Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner', 'armGroupLabels': ['Gymnema Sylvestre']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Calcined Magnesia'], 'description': 'Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Esperanza Martínez-Abundis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Esperanza Martínez-Abundis', 'investigatorAffiliation': 'University of Guadalajara'}}}}