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Clinical Trial Details

Trial ID: L2153
Source ID: NCT03606694
Associated Drug: Dihydromyricetin
Title: Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Dihydromyricetin|DRUG: Metformin
Outcome Measures: Primary: Fasting glucose, 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., Baseline to Week 12|Postprandial glucose, 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., Baseline to Week 12|Glycosylated hemoglobin, 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., Baseline to Week 12|Insulin sensitivity, Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12., Baseline to Week 12|Total insulin secretion, 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., Baseline to Week 12|First phase of insulin secretion, 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., Baseline to Week 12 | Secondary: Waist Circumference, Waist circumference will be evaluated at baseline and at week 12 with a flexible tape., Baseline to Week 12|Body Weigh, 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., Baseline, week 4, week 8 and week 12|Body Mass Index, 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., Baseline, week 4, week 8 and week 12|C reactive protein, 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, Baseline to Week 12|Interleukin 6, 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, Baseline to Week 12|Total Cholesterol, 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, Baseline to Week 12|Triglycerides levels, 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, Baseline to Week 12|High Density Lipoprotein (c-HDL) levels, 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, Basline to Week 12|Low Density Lipoproteins (c-LDL) levels, 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, Baseline to Week 12|Creatinine levels, Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques, Baseline to Week 12|Alanine aminotransferase (ALT) levels, ALT levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques, Baseline to Week 12|Aspartate aminotransferase (AST) levels, AST levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques, Baseline to Week 12|Blood pressure, 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, Baseline to Week 12
Sponsor/Collaborators: Sponsor: University of Guadalajara
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-10-30
Completion Date: 2023-12-30
Results First Posted:
Last Update Posted: 2023-05-23
Locations: Instituto de TerapeĂștica Experimental y ClĂ­nica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, 44340, Mexico
URL: https://clinicaltrials.gov/show/NCT03606694