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

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.

Study Overview

• Status: Unknown
• Conditions: Gestational Diabetes
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Resveratrol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Danielle M Stringer, PhD; Phone Number: (204) 789-3273; Email: dstringer@mich.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Recruiting
      • Manitoba Institute of Child Health
      • Principal Investigator: Shayne P Taback, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Corn starch capsules, 1 capsule twice a day for 3 months	Dietary supplement: Placebo; Other Names: Corn starch capsules
Experimental: Resveratrol; 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; Other Names: All Natural Resveratrol 98% Super Strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change in C-reactive protein		baseline and 3 months after intervention
change in glycated hemoglobin		baseline and 3 months after intervention
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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Manitoba Institute of Child Health
• Investigators: Principal Investigator: Shayne P Taback, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: May 9, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: beta cell function; history; resveratrol,; gestational diabetes,
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pregnancy Complications; Diabetes Mellitus; Insulin Resistance; Diabetes, Gestational; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: B2013:151