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

NCT ID: NCT02549924

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-02-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Resveratrol

Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DRUG

Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal

Placebo

Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules, 500 mg 3 times daily with the first bite of each meal

Interventions

Resveratrol

Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal

Intervention Type: DRUG

Placebo

Placebo capsules, 500 mg 3 times daily with the first bite of each meal

Intervention Type: DRUG

Other Intervention Names

Trans-resveratrol; Calcined Magnesia

Eligibility 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]

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Esperanza Martínez-Abundis

Esperanza Martínez-Abundis, FACP, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esperanza Martínez-Abundis, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Locations

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

ERVGDM2

Identifier Type: -

Identifier Source: org_study_id