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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Dietary Supplement: Resveratrol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Corn starch capsules, 1 capsule twice a day for 3 months | Dietary Supplement: Placebo<br> <br> * Other names: Corn starch capsules;|
| Experimental: Resveratrol<br>Resveratrol capsules, 250 mg twice a day for 3 months | Dietary Supplement: Resveratrol<br>* gel-coated capsules to be taken twice a day; one with breakfast and dinner<br>* Other names: All Natural Resveratrol 98% Super Strength;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in beta cell function | 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. | baseline and 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in insulin sensitivity | Insulin sensitivity will be assessed by calculating the homeostasis model of assessment of insulin resistance (HOMA-IR). | baseline and 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resveratrol,, gestational diabetes,, beta cell function, history