NCT02549924

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Guadalajara · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective is to evaluate the effect of administration of resveratrol on GV in individuals with T2DM inadequately controlled on metformin, for which we will conduct a double-blind trial, randomized, placebo control group, each group 11 male and female patients 30-60 years of age with T2DM inadequately controlled with metformin \[2000 mg / day and glycosylated hemoglobin A1c (A1C) ≥% 7\], with body mass index \[BMI\] form 25.0 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 8-week trial \[resveratrol capsules, 500 mg 3 times daily with the first bite of each meal or approved placebo capsules\], both groups also continue with metformin. The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at 8 weeks. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit, likewise, plasma glucose concentrations every hour recorded over 72 hours by continuous monitoring system outpatient glucose \[MACG\] via iPro ™ 2 \[Medtronic MiniMed, Northridge\] system, through which the mean amplitude of glucose excursions \[MAGE\] is calculated and AUC glucose, which will serve to assess the GV. 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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Resveratrol	Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal
DRUG	Placebo	Placebo capsules, 500 mg 3 times daily with the first bite of each meal

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-01-01
• Completion: 2018-02-01
• First posted: 2015-09-15
• Last updated: 2018-05-08

Locations

1 site across 1 country: Mexico