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

NCT01997762 | Unknown Phase 4 DMC

• 1 other identifier: B2013:151
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  baseline and 3 months after intervention

Other Outcomes (5)

• change in liver function

  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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Resveratrol

EXPERIMENTAL

Resveratrol capsules, 250 mg twice a day for 3 months

Dietary Supplement: Resveratrol

Interventions

Resveratrol DIETARY_SUPPLEMENT

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

Also known as: All Natural Resveratrol 98% Super Strength

Resveratrol

Placebo DIETARY_SUPPLEMENT

Also known as: Corn starch capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Institute of Child Health: collaborator

Study Sites (1)

Manitoba Institute of Child Health

Winnipeg, Manitoba, R3E 3P4, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Resveratrol; Starch

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Shayne P Taback, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle M Stringer, PhD

CONTACT

(204) 789-3273; dstringer@mich.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 28, 2013
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 12, 2014

Record last verified: 2013-11

Locations

CA (1)