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Polyphenol
Resveratrol for Gestational Diabetes
Phase 4
Waitlist Available
Led By Shayne P Taback, MD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months after intervention
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial tests if resveratrol supplements can help post-partum women who had gestational diabetes by keeping their insulin-producing cells healthy and improving their body's use of insulin. Resveratrol has been studied for its potential benefits in improving insulin sensitivity and glycemic control in various populations, including those with type 2 diabetes and metabolic syndrome.
Eligible Conditions
- Gestational Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 months after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months after intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in beta cell function
Secondary study objectives
Change in insulin sensitivity
Other study objectives
change in liver function
Side effects data
From 2013 Phase 2 trial • 24 Patients • NCT0211489225%
Headache
8%
Abdominal pain
8%
Sickness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Resveratrol
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ResveratrolExperimental Treatment1 Intervention
Resveratrol capsules, 250 mg twice a day for 3 months
Group II: PlaceboPlacebo Group1 Intervention
Corn starch capsules, 1 capsule twice a day for 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resveratrol
2014
Completed Phase 3
~730
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
618 Previous Clinical Trials
206,597 Total Patients Enrolled
Manitoba Institute of Child HealthIndustry Sponsor
8 Previous Clinical Trials
6,816 Total Patients Enrolled
Shayne P Taback, MDPrincipal InvestigatorUniversity of Manitoba
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