Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus

• Status: Terminated
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Type 2 diabetes mellitus [ T2DM ] has quickly become the epidemic of the XXI century and challenging global health . Estimates of the World Health Organization [ WHO ] indicate that globally , from 1995 to date has nearly tripled the number of people living with diabetes mellitus [DM ]. Resveratrol has been extensively studied as a regulator of glucose through its antioxidant effects and protecting pancreatic β cells by activation of sirtuin -1 [ SIRT1 ] dependent deacetylase nicotinamide adenine diphosphate [ NAD ]. Therefore, it is important to know the effect of resveratrol on the glycemic variability [GV ] in patients with T2DM who are not in control with metformin monotherapy based.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Resveratrol

Criteria

Inclusion Criteria:

• BMI from 25.0-34.9 kg/m2

• Diagnosis of T2DM

• Fasting plasma glucose >130 and <250 mg/dl at the time of scrutiny

• A1C between 7 and 10%

• Metformin monotherapy

• Written informed consent

Exclusion Criteria:

• Women pregnant or breastfeeding

• Untreated thyroid disease and/or uncontrolled hypertension [≥150 systolic and diastolic ≥90]

• Consumption of oral agents or other medications or supplements, unlike metformin, with proven properties that modify the behavior of glucose

• Total cholesterol >400 mg/dL

• Triglycerides ≥400 mg/dL

• Liver enzymes [ALT and AST] more than twice the normal range

• Glomerular filtration rate <60 mL/min [Cockcroft-Gault]