Clinical trial NCT01997762: Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?
Official title: Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gestational Diabetes
Keywords: resveratrol,
gestational diabetes,
beta cell function
history
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Institute of Child Health
First posted: 2013-11-28
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in beta cell function
timeFrame: baseline and 3 months after intervention
Secondary outcomes:
measure: recruitment rates
timeFrame: recruitment rates will be followed throughout the recruitment phase, which is expected to take 2 years maximum
measure: treatment adherence
timeFrame: 3 months after intervention
measure: Change in insulin sensitivity
timeFrame: baseline and 3 months after intervention
Other outcomes:
measure: change in liver function
timeFrame: baseline and 3 months after intervention
measure: change in C-reactive protein
timeFrame: baseline and 3 months after intervention
measure: change in glycated hemoglobin
timeFrame: baseline and 3 months after intervention
measure: change in serum lipids
timeFrame: baseline and 3 months after intervention
measure: change in plasma levels of resveratrol and resveratrol metabolites
timeFrame: baseline and 3 months after intervention
Locations:
city: Winnipeg
country: Canada
facility: Manitoba Institute of Child Health
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Shayne P Taback, MD
role: PRINCIPAL_INVESTIGATOR
References: