Ignite Creation Date:
2024-05-06 @ 7:28 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02549924
Status:
TERMINATED
Last Update Posted:
2018-05-08
First Post:
2015-09-09
Brief Title:
Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus
Sponsor:
University of Guadalajara
Organization:
University of Guadalajara
Study Overview
Official Title:
Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no financial support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 250 to 349 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None