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

University of Manitoba

Status and phase: Unknown; Phase 4

Conditions: Gestational Diabetes

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Resveratrol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01997762

B2013:151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Corn starch capsules, 1 capsule twice a day for 3 months

Treatment:

Dietary Supplement: Placebo

Resveratrol

Experimental group

Description:

Resveratrol capsules, 250 mg twice a day for 3 months

Treatment:

Dietary Supplement: Resveratrol