Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT03606694
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2018-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C472036', 'term': 'dihydromyricetin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': 'Baseline to Week 12', 'description': 'Changes in fasting glucose levels after 12 weeks of intervention with dihydromyricetin and metformin. The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12.'}, {'measure': 'Postprandial glucose', 'timeFrame': 'Baseline to Week 12', 'description': 'Changes in postprandial glucose levels after 12 weeks of intervention with dihydromyricetin and metformin. Postprandial glucose will be evaluated at baseline and 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', 'timeFrame': 'Baseline to Week 12', 'description': 'Changes in glycosylated hemoglobin (A1C) after 12 weeks of intervention with dihydromyricetin and metformin. Glycosylated hemoglobin will be evaluated at baseline and week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12.'}, {'measure': 'Insulin sensitivity', 'timeFrame': 'Baseline to Week 12', 'description': 'Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12.'}, {'measure': 'Total insulin secretion', 'timeFrame': 'Baseline to Week 12', 'description': 'Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12.'}, {'measure': 'First phase of insulin secretion', 'timeFrame': 'Baseline to Week 12', 'description': 'The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12.'}], 'secondaryOutcomes': [{'measure': 'Waist Circumference', 'timeFrame': 'Baseline to Week 12', 'description': 'Waist circumference will be evaluated at baseline and at week 12 with a flexible tape.'}, {'measure': 'Body Weigh', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'The body weight will be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12.'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Body Mas Index will be calculated at baseline, week 4, week 8 and week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12.'}, {'measure': 'C reactive protein', 'timeFrame': 'Baseline to Week 12', 'description': 'C reactive protein will be evaluated at baseline and week 12 by enzyme-linked immunosorbent assay (ELISA) and the entered values reflect the creatinine levels at week 12'}, {'measure': 'Interleukin 6', 'timeFrame': 'Baseline to Week 12', 'description': 'Interleukin 6 will be evaluated at the beginning and during week 12 using the enzyme-linked immunosorbent assay (ELISA) and the values entered reflect creatinine levels at week 12'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Baseline to Week 12', 'description': 'Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12'}, {'measure': 'Triglycerides levels', 'timeFrame': 'Baseline to Week 12', 'description': 'Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12'}, {'measure': 'High Density Lipoprotein (c-HDL) levels', 'timeFrame': 'Basline to Week 12', 'description': 'c-HDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12'}, {'measure': 'Low Density Lipoproteins (c-LDL) levels', 'timeFrame': 'Baseline to Week 12', 'description': 'c-LDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12'}, {'measure': 'Creatinine levels', 'timeFrame': 'Baseline to Week 12', 'description': 'Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques'}, {'measure': 'Alanine aminotransferase (ALT) levels', 'timeFrame': 'Baseline to Week 12', 'description': 'ALT levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques'}, {'measure': 'Aspartate aminotransferase (AST) levels', 'timeFrame': 'Baseline to Week 12', 'description': 'AST levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline to Week 12', 'description': 'Blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dihydromyricetin', 'metformin', 'type 2 diabetes mellitus'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Dihydromyricetin has demonstrated promising effects in glycemic control, insulin sensitivity and insulin secretion, that above mentioned findings show that dihydromyricetin has an excellent potential effect in the treatment of type 2 diabetes mellitus patients.', 'detailedDescription': "A double-blind, randomized clinical trial of three pharmacological groups in 36 patients with a diagnosis of type 2 diabetes mellitus in accordance with the American Diabetes Association (ADA) without treatment.\n\nThey will be assigned randomly two groups of 12 patients, each one will receive dihydromyricetin 300 mg or metformin 850 mg, two times per day before having break-fast and before having dinner during 12 weeks.\n\nThe Area Under the Curve of glucose and insulin will be calculated, total insulin secretion (Insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).\n\nThis protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.\n\nStatistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05."}, '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* Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels \\>126 mg/dL; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose \\>200 mg/dl; or glycosylated hemoglobin between \\>6.5%)\n* Informed consent signed\n\nExclusion Criteria:\n\n* Women with confirmed or suspected pregnancy, or under lactation and/or puerperium\n* Previous treatment for glucose\n* Fasting glucose ≥250 mg/dL\n* Body Mass Index ≥34.9 kg/m2\n* Known uncontrolled renal, hepatic, heart or thyroid diseased\n* Hypersensibility to ingredients of intervention\n* Triglycerides ≥500 mg/dL\n* Total cholesterol ≥240 mg/dL\n* Blood Pressure ≥140/90 mmHg'}, 'identificationModule': {'nctId': 'NCT03606694', 'briefTitle': 'Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of Dihydromirycetin Administration on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'DHM-Metformin-T2DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dihydromyricetin', 'description': 'Dihydromyricetin capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.', 'interventionNames': ['Drug: Dihydromyricetin']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Dihydromyricetin', 'type': 'DRUG', 'otherNames': ['Ampelopsis grossedentata Extract'], 'description': 'The intervention wiil be 300 mg, two times per day before break-fast and dinner during 12 weeks.', 'armGroupLabels': ['Dihydromyricetin']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Brad Predial'], 'description': 'The intervention wiil be 850 mg, two times per day before break-fast and dinner during 12 weeks.', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Instituto 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 ORTIZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karina Griselda Pérez Rubio', 'investigatorAffiliation': 'University of Guadalajara'}}}}