24 Participants Needed

Resveratrol for Type 1 Diabetes

(T-St1M Trial)

RA
CD
JL
Overseen ByJacob Looney, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed study is designed to test the hypothesis that treatment of resveratrol for 12 weeks will improve both endothelin-B receptor (aim 1) and skeletal muscle mitochondrial function (aim 2) in people with type 1 diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using vasoactive medications (drugs that affect blood vessel function).

Is resveratrol safe for humans?

Resveratrol is generally well-tolerated in humans, as shown in studies with older adults and healthy volunteers, where no significant adverse effects were reported. It has been tested in various doses and conditions, and blood chemistry values remained normal, indicating its safety.12345

How does the drug resveratrol differ from other treatments for type 1 diabetes?

Resveratrol is a natural compound found in foods like grapes and wine, and it may help improve blood sugar control and insulin activity in type 1 diabetes. Unlike standard insulin therapy, resveratrol also has antioxidant and anti-inflammatory properties, which could provide additional health benefits.35678

What evidence supports the effectiveness of resveratrol as a treatment for type 1 diabetes?

Research shows that resveratrol, a compound found in red wine and other foods, can help protect against diabetes in animal studies by lowering blood sugar levels and improving insulin function. It has also been shown to improve blood sugar control in diabetic rats, suggesting potential benefits for type 1 diabetes.356910

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a man or a premenopausal woman.
I have type 1 diabetes and need insulin.
I am a man or a premenopausal woman.
See 1 more

Exclusion Criteria

I have complications from diabetes, like nerve damage.
My diabetes is not under control (HbA1C >12%).
I have been diagnosed with liver, heart, or kidney disease.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive resveratrol or placebo for 12 weeks to assess ETBR and skeletal muscle mitochondrial function

12 weeks
Baseline and post 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Resveratrol
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Individuals with type 1 diabetesExperimental Treatment2 Interventions
Group II: Healthy ControlsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials
219
Recruited
85,900+

Published Research Related to This Trial

Resveratrol and 17β-estradiol both demonstrated protective effects against type 1 diabetes in ovariectomized mice, significantly lowering blood glucose levels and improving insulin and antioxidant capacity over a 4-week treatment period.
The mechanisms of action for these compounds include enhancing pancreatic islet function, promoting glucose uptake in muscles, and reducing oxidative stress, indicating their potential as therapeutic agents for diabetes management.
Preventative effects of resveratrol and estradiol on streptozotocin-induced diabetes in ovariectomized mice and the related mechanisms.Li, Y., Huang, J., Yan, Y., et al.[2019]
A systematic review of six randomized controlled trials involving 196 patients with type 2 diabetes showed that resveratrol supplementation significantly improved systolic blood pressure, hemoglobin A1c, and creatinine levels compared to placebo.
Resveratrol was found to have a good safety profile, with no major adverse events reported, suggesting it could be a beneficial adjunct to existing diabetes treatments, despite limitations in sample size and treatment duration.
Resveratrol treatment as an adjunct to pharmacological management in type 2 diabetes mellitus--systematic review and meta-analysis.Hausenblas, HA., Schoulda, JA., Smoliga, JM.[2022]
Resveratrol, found in foods like wine and berries, has potential health benefits against various conditions such as diabetes, inflammation, and cancer, making it a promising compound for disease prevention.
Despite its many benefits, resveratrol has low bioavailability and solubility, which may limit its effectiveness in clinical applications, highlighting the need for improved delivery methods.
Health benefits of resveratrol administration.Galiniak, S., Aebisher, D., Bartusik-Aebisher, D.[2019]

Citations

Preventative effects of resveratrol and estradiol on streptozotocin-induced diabetes in ovariectomized mice and the related mechanisms. [2019]
Resveratrol treatment as an adjunct to pharmacological management in type 2 diabetes mellitus--systematic review and meta-analysis. [2022]
Health benefits of resveratrol administration. [2019]
Resveratrol improves glycemic control in insulin-treated diabetic rats: participation of the hepatic territory. [2020]
Health benefits of resveratrol: Evidence from clinical studies. [2020]
Antiplatelet activity of cis-resveratrol. [2018]
Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study. [2022]
Pharmacokinetic and safety profile of trans-resveratrol in a rising multiple-dose study in healthy volunteers. [2022]
Resveratrol and diabetes: from animal to human studies. [2022]
Resveratrol, a natural phytoalexin, normalizes hyperglycemia in streptozotocin-nicotinamide induced experimental diabetic rats. [2022]
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