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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post 12 weeks

Awards & highlights

T-St1M Trial 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.Check my eligibility

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.See study design

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.

T-St1M Trial 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.

T-St1M Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in AUC for ET-1 + BQ-123

Skeletal Muscle Mitochondrial Function

Secondary outcome measures

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

Abdominal pain

Sickness

100%

80%

60%

40%

20%

Study treatment Arm

Resveratrol

Placebo

T-St1M 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor

211 Previous Clinical Trials

85,044 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently involved in this research endeavor?

"That is correct. According to clinicaltrials.gov, the research project which was first launched on October 14th 2020 is still in need of participants. 24 individuals are needed from a single trial site."

Answered by AI

Are there any further experiments that have been conducted on Resveratrol?

"At the current moment, 5 clinical trials for resveratrol are taking place. One of these is in phase 3 with 8 separate sites located primarily within Cincinnati, Ohio."

Answered by AI

Are there vacancies for individuals to participate in this research?

"Information sourced from clinicaltrials.gov suggests this medical trial is actively seeking participants, with the original posting date being October 14th 2020 and last edit on July 18th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Type 1 Diabetes, Endothelin, and Skeletal Muscle Mitochondrial Dysfunction: The Role of Sirtuin-1

Ryan Harris 2020. "Type 1 Diabetes, Endothelin, and Skeletal Muscle Mitochondrial Dysfunction: The Role of Sirtuin-1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04449198.

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