A Phase 4 interventional study of Resveratrol and Placebo in Gestational Diabetes, sponsored by University of Manitoba. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-12.
Sponsored by University of Manitoba · Phase 4, Interventional, and Prevention
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 112 is close to the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Corn starch capsules, 1 capsule twice a day for 3 months
Dietary Supplement: Placebo
Resveratrol capsules, 250 mg twice a day for 3 months
Dietary Supplement: Resveratrol
gel-coated capsules to be taken twice a day; one with breakfast and dinner
Also known as: All Natural Resveratrol 98% Super Strength
Also known as: Corn starch capsules
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.
Time frame: baseline and 3 months after intervention
recruitment rates
Time frame: recruitment rates will be followed throughout the recruitment phase, which is expected to take 2 years maximum
treatment adherence
Time frame: 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).
Time frame: baseline and 3 months after intervention
change in liver function
liver function will be assessed by measuring plasma concentrations of alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin and conjugated bilirubin.
Time frame: baseline and 3 months after intervention
change in C-reactive protein
Time frame: baseline and 3 months after intervention
change in glycated hemoglobin
Time frame: baseline and 3 months after intervention
change in serum lipids
Time frame: baseline and 3 months after intervention
change in plasma levels of resveratrol and resveratrol metabolites
Time frame: baseline and 3 months after intervention
This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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University of Manitoba