← Back to Search

Resveratrol for Type 1 Diabetes (T-St1M Trial)

Phase < 1
Recruiting
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)
Be older than 18 years old
Must not have
Diabetic complications (i.e. neuropathy)
Uncontrolled diabetes (HbA1C >12%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post 12 weeks

Summary

This trial will test whether resveratrol can improve function in people with type 1 diabetes.

Who is the study for?
This trial is for men and premenopausal women of all races with a clinical diagnosis of insulin-dependent type 1 diabetes. Participants should not be pregnant, have uncontrolled diabetes (HbA1C >12%), diabetic complications like neuropathy, or diagnosed liver, heart, or kidney diseases. They also shouldn't have high blood pressure (>140/90 mm Hg on therapy) or be taking vasoactive medications.
What is being tested?
The study is testing if resveratrol taken for 12 weeks can improve the function of endothelin-B receptors and skeletal muscle mitochondria in people with type 1 diabetes. A placebo group will serve as the comparison to see if there's a real effect from resveratrol.
What are the potential side effects?
While specific side effects are not listed here, generally speaking, resveratrol may cause mild to moderate digestive issues such as nausea or diarrhea in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have type 1 diabetes and need insulin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have complications from diabetes, like nerve damage.
Select...
My diabetes is not under control (HbA1C >12%).
Select...
I have been diagnosed with liver, heart, or kidney disease.
Select...
I am taking medication that affects blood vessel tension.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in AUC for ET-1 + BQ-123
Skeletal Muscle Mitochondrial Function
Secondary study objectives
Change in Percentage Flow-Mediated Dilation (FMD)
Change in Post Occlusive Reactive Hyperemia (PORH)
Change in Pulse Wave Velocity (PWV)

Side effects data

From 2013 Phase 2 trial • 24 Patients • NCT02114892
25%
Headache
8%
Abdominal pain
8%
Sickness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Resveratrol
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Individuals with type 1 diabetesExperimental Treatment2 Interventions
Individuals with type 1 diabetes will be randomly assigned to 1 of the 2 interventions (Resveratrol or placebo)
Group II: Healthy ControlsActive Control1 Intervention
Healthy individuals who participate will receive no intervention and serve as controls.
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?

Augusta UniversityLead Sponsor
215 Previous Clinical Trials
85,666 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04449198 — Phase < 1
Type 1 Diabetes Research Study Groups: Healthy Controls, Individuals with type 1 diabetes
Type 1 Diabetes Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04449198 — Phase < 1
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04449198 — Phase < 1
~0 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top