Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|