Resveratrol for Type 1 Diabetes

(T-St1M Trial)

Overseen By Jacob Looney, MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Augusta University

Must not be taking: Vasoactive medications

Disqualifiers: Hepatic, cardiovascular, renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 12-week treatment with resveratrol can improve heart and muscle function in people with type 1 diabetes. Resveratrol, a natural compound found in foods like grapes and berries, will be administered to participants, who will receive either resveratrol or a placebo (a pill with no active ingredients) to compare effects. Individuals diagnosed with type 1 diabetes who manage their condition well, without serious complications, may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how resveratrol works in people, offering participants a chance to be among the first to receive this treatment.

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 there any evidence suggesting that resveratrol is likely to be safe for humans?

Research has shown that resveratrol has been tested in people with type 1 diabetes. One study found that taking resveratrol for 60 days significantly lowered blood sugar and reduced cell damage. After 6 months, participants taking resveratrol showed improved blood sugar and cholesterol levels compared to their initial measurements. These results suggest that resveratrol is generally safe and might aid in managing diabetes-related health issues. However, further studies are needed to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Unlike the standard treatments for type 1 diabetes, which typically focus on insulin replacement, Resveratrol is unique because it is a natural compound found in grapes and berries that may have anti-inflammatory and antioxidant properties. Researchers are excited about Resveratrol because it could potentially protect pancreatic beta cells and improve insulin sensitivity, offering a novel approach to managing the disease. This could lead to fewer complications and a better quality of life for individuals with type 1 diabetes.

What evidence suggests that resveratrol might be an effective treatment for type 1 diabetes?

Research has shown that resveratrol might benefit people with Type 1 diabetes. In studies, taking resveratrol for 60 days effectively managed blood sugar levels. Another study found that after six months, resveratrol significantly lowered fasting blood sugar, HbA1c, triglycerides, and cholesterol. In this trial, researchers will randomly assign individuals with Type 1 diabetes to receive either resveratrol or a placebo. These findings suggest that resveratrol could improve how the body processes sugar and fats, potentially making it a useful addition to diabetes care. ^{1 2 5 6 7}

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.

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.

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?

Group I: Individuals with type 1 diabetes Experimental Treatment 2 Interventions

Individuals with type 1 diabetes will be randomly assigned to 1 of the 2 interventions (Resveratrol or placebo)

Group II: Healthy Controls Active Control 1 Intervention

Healthy individuals who participate will receive no intervention and serve as controls.

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Published Research Related to This Trial

In a study using a type 1 diabetes model in rats, resveratrol improved glycemic control when used alongside insulin therapy, restoring plasma fructosamine levels to those of non-diabetic rats.

The beneficial effects of resveratrol were linked to changes in liver function, including reduced expression of glucose production-related genes and increased glycogen storage, rather than altering glucose transport in the intestine or kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resveratrol improves glycemic control in insulin-treated diabetic rats: participation of the hepatic territory. Yonamine, CY., Pinheiro-Machado, E., Michalani, ML., et al.[2020]

Cis-resveratrol significantly reduces collagen-induced platelet aggregation in vitro, with a decrease of 43.5% at a concentration of 1 x 10(-5) M, indicating its potential as an anti-aggregating agent.

Trans-resveratrol also shows anti-aggregating effects but is slightly less effective than cis-resveratrol, suggesting that both isomers should be considered when evaluating resveratrol's overall activity in biological systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplatelet activity of cis-resveratrol. Bertelli, AA., Giovannini, L., Bernini, W., et al.[2018]

Resveratrol, a natural polyphenol, has shown promising anti-diabetic effects in both animal models and preliminary clinical trials, improving glucose homeostasis and decreasing insulin resistance in type 2 diabetic patients.

The beneficial effects of resveratrol are linked to its ability to enhance the activity of AMPK and SIRT1, along with its antioxidant and anti-inflammatory properties, suggesting it could be a valuable addition to conventional diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resveratrol and diabetes: from animal to human studies. Szkudelski, T., Szkudelska, K.[2022]

A double-blind, randomized, placebo-controlled trial involving 32 overweight older adults showed that resveratrol supplementation at doses of 300mg and 1000mg per day is safe and well-tolerated, with no significant adverse effects reported.

Participants taking resveratrol experienced significantly lower glucose levels compared to those on placebo, suggesting potential benefits for metabolic health, although their glucose levels did not differ from their baseline measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study. Anton, SD., Embry, C., Marsiske, M., et al.[2022]

In a study involving 40 healthy adults, trans-resveratrol was administered in varying doses (25 to 150 mg) six times a day, showing that it reached peak plasma concentrations within 0.8 to 1.5 hours after dosing, but overall plasma levels remained relatively low despite high doses.

The treatment was well-tolerated with only mild adverse events reported, and the bioavailability of trans-resveratrol was found to be higher when taken in the morning, indicating potential timing considerations for optimal effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and safety profile of trans-resveratrol in a rising multiple-dose study in healthy volunteers. Almeida, L., Vaz-da-Silva, M., Falcão, A., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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, a polyphenolic nutraceutical, has shown potential benefits in over 244 clinical trials for various conditions including diabetes, cancer, and cardiovascular diseases, indicating its broad therapeutic efficacy.

Despite its safety at doses up to 5 g/day, resveratrol's clinical use has been limited by rapid metabolism and poor bioavailability, although a new formulation called SRT501 may enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of resveratrol: Evidence from clinical studies. Singh, AP., Singh, R., Verma, SS., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of resveratrol administration. Galiniak, S., Aebisher, D., Bartusik-Aebisher, D.[2019]

In a study involving diabetic rats treated with resveratrol for 30 days, significant reductions in blood glucose and other harmful metabolic markers were observed, indicating its potential as an antidiabetic agent.

Resveratrol's effects were comparable to the standard diabetes medication glyclazide, suggesting it could be an effective alternative for managing diabetes mellitus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resveratrol, a natural phytoalexin, normalizes hyperglycemia in streptozotocin-nicotinamide induced experimental diabetic rats. Palsamy, P., Subramanian, S.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7019753/

Efficacy and Safety of Resveratrol in Type 1 Diabetes Patients The results showed that 60 days of resveratrol supplementation exerted strong antidiabetic and antioxidant effects in patients with T1D.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31935938/

Efficacy and Safety of Resveratrol in Type 1 Diabetes ... The results showed that 60 days of resveratrol supplementation exerted strong antidiabetic and antioxidant effects in patients with T1D.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0753332217327683

Resveratrol and diabetes: A critical review of clinical studies Resveratrol supplement may be effective in improving glycemic control and could be provided as an adjuvant for the treatment and management of diabetes [1]. In ...

4. academic.oup.com academic.oup.com/qjmed/article/117/Supplement_1/hcae070.480/7704763

Efficacy and Safety of Resveratrol in Patients with Type 1 ... After 6 months, resveratrol therapy resulted in a significant decrease of FBG, HbA1c, triglycerides and total cholesterol compared with baseline ...

5. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2022.795980/full

Efficacy of Resveratrol Supplementation on Glucose and ... Regarding different types of disease, we found that RSV supplementation significantly decreased TC and LDL-C in patients with T2DM vs. obese ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8410426/

Efficacy and Safety of Resveratrol Supplements on Blood ... Studies have shown that resveratrol has shown great beneficial effects on hyperglycemia, insulin resistance, and antioxidant [11, 12]. Clinical trials have ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0753332219353892

A review on the potential of Resveratrol in prevention and ... The present findings showed that treatment with resveratrol prevents the increase in AChE activity and consequently memory impairment in diabetic rats, ...