Trial record 16 of 101 for:    Open Studies | "Diabetes, Gestational"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Manitoba
Sponsor:
Collaborator:
Manitoba Institute of Child Health
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01997762
First received: November 13, 2013
Last updated: May 9, 2014
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • treatment adherence [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
  • Change in insulin sensitivity [ Time Frame: baseline and 3 months after intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • change in glycated hemoglobin [ Time Frame: baseline and 3 months after intervention ] [ Designated as safety issue: No ]
  • change in serum lipids [ Time Frame: baseline and 3 months after intervention ] [ Designated as safety issue: No ]
  • change in plasma levels of resveratrol and resveratrol metabolites [ Time Frame: baseline and 3 months after intervention ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01997762     History of Changes
Other Study ID Numbers: B2013:151
Study First Received: November 13, 2013
Last Updated: May 9, 2014
Health Authority: Canada: Research Ethics Board

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

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

ClinicalTrials.gov processed this record on July 24, 2014