Gestational Diabetes
Conditions
Keywords
resveratrol,, gestational diabetes,, beta cell function, history
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
DIETARY_SUPPLEMENTResveratrol
gel-coated capsules to be taken twice a day; one with breakfast and dinner
Sponsors
Manitoba Institute of Child Health
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in serum lipids | baseline and 3 months after intervention | — |
| change in plasma levels of resveratrol and resveratrol metabolites | baseline and 3 months after intervention | — |
| change in liver function | 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 | baseline and 3 months after intervention | — |
| change in glycated hemoglobin | baseline and 3 months after intervention | — |
Countries
Canada
Contacts
Primary ContactDanielle M Stringer, PhD
Outcome results
None listed