Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?

Phase 4

• Conditions: Gestational Diabetes
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Resveratrol

• Registration Number: NCT01997762
• Lead Sponsor: University of Manitoba

Brief Summary

The purpose of this study is to determine if resveratrol supplementation preserves beta cell function and insulin sensitivity in post-partum women following a first diagnosis of gestational diabetes. We hypothesize that daily supplementation with resveratrol will preserve beta cell function and insulin sensitivity.

Detailed Description

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 Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-11-28
• Study Start: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

• Adult women (18 years of age or older) 3 months post-partum with a recent history of first diagnosis of gestational diabetes.
• Willingness to provide informed consent 3 months post-partum.

Exclusion Criteria

• Abnormal glucose tolerance or type 2 diabetes recorded at 3 months post-partum.
• Breastfeeding beyond 9 months post-partum.
• Intention to consume resveratrol open label.
• Intention to drink red wine (more than 4 glasses per week) or eat foods high in resveratrol (grapes, grape juice, peanuts, peanut products).
• Unwillingness to use two approved types of contraception until one year post-partum and unwillingness to undergo pregnancy test at randomization.
• Twin pregnancy.
• Consuming medications with a risk of interaction with resveratrol.
• Liver disease.
• Unlikely to be able to comply with study follow-up as judged by social (e.g. transient, not permanent residents, etc.) or geographical considerations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Corn starch capsules, 1 capsule twice a day for 3 months
Resveratrol	Resveratrol	Resveratrol capsules, 250 mg twice a day for 3 months

Primary Outcome Measures

Name	Time	Method
Change in beta cell function	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.

Secondary Outcome Measures

Name	Time	Method
Change in insulin sensitivity	baseline and 3 months after intervention	Insulin sensitivity will be assessed by calculating the homeostasis model of assessment of insulin resistance (HOMA-IR).
recruitment rates	recruitment rates will be followed throughout the recruitment phase, which is expected to take 2 years maximum
treatment adherence	3 months after intervention

Trial Locations

Locations (1)

Manitoba Institute of Child Health; 🇨🇦 Winnipeg, Manitoba, Canada