Clinical trial NCT02549924: Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus
Official title: Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Resveratrol
Glycemic Variability
MAGE
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \[Cockcroft-Gault\]

Primary outcomes:
measure: Area under the curve
timeFrame: 56 days
measure: Mean amplitude of glucose excursions (MAGE)
timeFrame: 56 days
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 56 days
measure: Postprandial glucose
timeFrame: 56 days
measure: A1C
timeFrame: 56 days
measure: Total cholesterol
timeFrame: 56 days
measure: Triglycerides
timeFrame: 56 days
measure: High-density lipoprotein cholesterol
timeFrame: 56 days
measure: Low-density lipoprotein cholesterol
timeFrame: 56 days
measure: Very-low density lipoprotein
timeFrame: 56 days
measure: Alanine aminotransferase
timeFrame: 56 days
measure: Aspartate aminotransferase
timeFrame: 56 days
measure: Creatinine
timeFrame: 56 days
measure: Blood pressure
timeFrame: 56 days
measure: Body and visceral fat %
timeFrame: 56 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
name: Esperanza Martínez-Abundis, PhD
role: PRINCIPAL_INVESTIGATOR
References: