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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02549924
• Other study ID #: ERVGDM2
• Status: Terminated
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: May 2018
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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]

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Resveratrol
Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal
• Placebo
Placebo capsules, 500 mg 3 times daily with the first bite of each meal

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve	Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2	56 days
Primary	Mean amplitude of glucose excursions (MAGE)	Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2	56 days
Secondary	Fasting plasma glucose	Before and after intervention by spectrophotometry	56 days
Secondary	Postprandial glucose	Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2	56 days
Secondary	A1C	Before and after intervention by high-performance liquid chromatography	56 days
Secondary	Total cholesterol	Before and after intervention by spectrophotometry	56 days
Secondary	Triglycerides	Before and after intervention by spectrophotometry	56 days
Secondary	High-density lipoprotein cholesterol	Before and after intervention by spectrophotometry	56 days
Secondary	Low-density lipoprotein cholesterol	Friedewald formula	56 days
Secondary	Very-low density lipoprotein	Friedewald formula	56 days
Secondary	Alanine aminotransferase	Before and after intervention by spectrophotometry	56 days
Secondary	Aspartate aminotransferase	Before and after intervention by spectrophotometry	56 days
Secondary	Creatinine	Before and after intervention by spectrophotometry	56 days
Secondary	Blood pressure	Before and after intervention using a digital manometer	56 days
Secondary	Body and visceral fat %	Before and after intervention using a impedance bascule, Tanita MR	56 days