Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?
|ClinicalTrials.gov Identifier: NCT01997762|
Recruitment Status : Unknown
Verified November 2013 by University of Manitoba.
Recruitment status was: Recruiting
First Posted : November 28, 2013
Last Update Posted : May 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Dietary Supplement: Resveratrol Dietary Supplement: Placebo||Phase 4|
Our primary aim is to perform a randomized controlled trial of resveratrol for the improvement of insulin sensitivity and the preservation of beta cell function in post-partum women following a first diagnosis of gestational diabetes. Our long-term goal is to test resveratrol for the secondary prevention of gestational diabetes and type 2 diabetes. We have developed six conditions that should be satisfied by the study to justify project expansion. Therefore, we will be testing hypotheses and computing estimates for the following six outcomes: (1) recruitment numbers, (2) adherence to study treatment, (3) adherence to study visits, (4) insulin sensitivity measured at 12 months post-partum, (5) beta cell function measured at 12 months post-partum, and (6) adverse events.
The study is a single-site, parallel, double-blind, randomized, placebo-controlled trial. The study population consists of women recruited during pregnancy who had a confirmed first diagnosis of gestational diabetes, who do not have either diabetes or pre-diabetes when re-tested 3 months post-partum, and who have stopped breastfeeding by 9 months post-partum. They study intervention is resveratrol (or identical placebo) twice daily for a total of 12 weeks from 9 months to 12 months post-partum. Our planned sample size is 112 women based on the hypothesis testing and estimation considerations for the six above-mentioned outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
Placebo Comparator: Placebo
Corn starch capsules, 1 capsule twice a day for 3 months
Dietary Supplement: Placebo
Other Name: Corn starch capsules
Resveratrol capsules, 250 mg twice a day for 3 months
Dietary Supplement: Resveratrol
gel-coated capsules to be taken twice a day; one with breakfast and dinner
Other Name: All Natural Resveratrol 98% Super Strength
- Change in beta cell function [ Time Frame: baseline and 3 months after intervention ]Beta cell function will be assessed by calculating the Insulin Secretion Sensitivity Index-2, a ratio of the area under the curve (AUC) for glucose and the AUC for insulin after an oral glucose tolerance test.
- recruitment rates [ Time Frame: recruitment rates will be followed throughout the recruitment phase, which is expected to take 2 years maximum ]
- treatment adherence [ Time Frame: 3 months after intervention ]
- Change in insulin sensitivity [ Time Frame: baseline and 3 months after intervention ]Insulin sensitivity will be assessed by calculating the homeostasis model of assessment of insulin resistance (HOMA-IR).
- change in liver function [ Time Frame: baseline and 3 months after intervention ]liver function will be assessed by measuring plasma concentrations of alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin and conjugated bilirubin.
- change in C-reactive protein [ Time Frame: baseline and 3 months after intervention ]
- change in glycated hemoglobin [ Time Frame: baseline and 3 months after intervention ]
- change in serum lipids [ Time Frame: baseline and 3 months after intervention ]
- change in plasma levels of resveratrol and resveratrol metabolites [ Time Frame: baseline and 3 months after intervention ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997762
|Contact: Danielle M Stringer, PhD||(204) firstname.lastname@example.org|
|Manitoba Institute of Child Health||Recruiting|
|Winnipeg, Manitoba, Canada, R3E 3P4|
|Principal Investigator: Shayne P Taback, MD|
|Principal Investigator:||Shayne P Taback, MD||University of Manitoba|