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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by University of Manitoba.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01997762
First Posted: November 28, 2013
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Manitoba Institute of Child Health
Information provided by (Responsible Party):
University of Manitoba
  Purpose
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.

Condition Intervention Phase
Gestational Diabetes Dietary Supplement: Resveratrol Dietary Supplement: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change in beta cell function [ Time Frame: 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 Outcome Measures:
  • 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 [ Time Frame: baseline and 3 months after intervention ]
    Insulin sensitivity will be assessed by calculating the homeostasis model of assessment of insulin resistance (HOMA-IR).


Other Outcome Measures:
  • change in liver function [ Time Frame: 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 [ 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 ]

Estimated Enrollment: 112
Study Start Date: May 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Corn starch capsules, 1 capsule twice a day for 3 months
Dietary Supplement: Placebo
Other Name: 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 Name: All Natural Resveratrol 98% Super Strength

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997762


Contacts
Contact: Danielle M Stringer, PhD (204) 789-3273 dstringer@mich.ca

Locations
Canada, Manitoba
Manitoba Institute of Child Health Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Principal Investigator: Shayne P Taback, MD         
Sponsors and Collaborators
University of Manitoba
Manitoba Institute of Child Health
Investigators
Principal Investigator: Shayne P Taback, MD University of Manitoba
  More Information

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01997762     History of Changes
Other Study ID Numbers: B2013:151
First Submitted: November 13, 2013
First Posted: November 28, 2013
Last Update Posted: May 12, 2014
Last Verified: November 2013

Keywords provided by University of Manitoba:
resveratrol,
gestational diabetes,
beta cell function
history

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Pregnancy Complications
Insulin
Resveratrol
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents