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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01997762
• Other study ID #: B2013:151
• Status: Recruiting
• Phase: Phase 4
• First received: November 13, 2013
• Last updated: May 9, 2014
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2013
• Source: University of Manitoba
• Contact: Danielle M Stringer, PhD
• Phone: (204) 789-3273
• Email: dstringer[@]mich.ca
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Dietary Supplement:
• Resveratrol
gel-coated capsules to be taken twice a day; one with breakfast and dinner
• Placebo

Locations

Country	Name	City	State
Canada	Manitoba Institute of Child Health	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Institute of Child Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	baseline and 3 months after intervention	Yes
Other	change in C-reactive protein		baseline and 3 months after intervention	Yes
Other	change in glycated hemoglobin		baseline and 3 months after intervention	No
Other	change in serum lipids		baseline and 3 months after intervention	No
Other	change in plasma levels of resveratrol and resveratrol metabolites		baseline and 3 months after intervention	No
Primary	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	No
Secondary	recruitment rates		recruitment rates will be followed throughout the recruitment phase, which is expected to take 2 years maximum	No
Secondary	treatment adherence		3 months after intervention	No
Secondary	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	No