Recruiting

Resveratrol

Sponsor:

University of Manitoba

Code:

NCT01997762

Conditions

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Resveratrol

Placebo

Study Details

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.

Conditions

Gestational Diabetes

Study ID

NCT01997762

Start date

May, 2014

Status verified date

Nov, 2013

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Corn starch capsules, 1 capsule twice a day for 3 months

experimental: Resveratrol

Resveratrol capsules, 250 mg twice a day for 3 months

Interventions

Resveratrol

gel-coated capsules to be taken twice a day; one with breakfast and dinner

Placebo

Primary outcome measure

  • Change in beta cell function [ Time Frame: baseline and 3 months after intervention ]

Central Contacts and Locations

Central contacts

Danielle M Stringer, PhD

(204) 789-3273dstringer@mich.ca

Locations

Manitoba Institute of Child Health

Recruiting

Winnipeg, Manitoba, Canada, R3E 3P4

Principal Investigator:

Shayne P Taback, MD

More Information

Sponsor

University of Manitoba

Last update posted

May 12, 2014

Last verified

Nov, 2013

Keywords

  • resveratrol,
  • gestational diabetes,
  • beta cell function
  • history

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2014-05-12.