Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus
- Registration Number
- NCT02549924
- Lead Sponsor
- University of Guadalajara
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%. Resveratrol Resveratrol Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.
- Primary Outcome Measures
Name Time Method Mean amplitude of glucose excursions (MAGE) 56 days Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2
Area under the curve 56 days Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2
- Secondary Outcome Measures
Name Time Method A1C 56 days Before and after intervention by high-performance liquid chromatography
Low-density lipoprotein cholesterol 56 days Friedewald formula
Very-low density lipoprotein 56 days Friedewald formula
Body and visceral fat % 56 days Before and after intervention using a impedance bascule, Tanita MR
Postprandial glucose 56 days Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2
Total cholesterol 56 days Before and after intervention by spectrophotometry
Alanine aminotransferase 56 days Before and after intervention by spectrophotometry
Aspartate aminotransferase 56 days Before and after intervention by spectrophotometry
Creatinine 56 days Before and after intervention by spectrophotometry
Blood pressure 56 days Before and after intervention using a digital manometer
High-density lipoprotein cholesterol 56 days Before and after intervention by spectrophotometry
Fasting plasma glucose 56 days Before and after intervention by spectrophotometry
Triglycerides 56 days Before and after intervention by spectrophotometry
Trial Locations
- Locations (1)
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico