Type 1 Diabetes, Endothelin, and Skeletal Muscle Mitochondrial Dysfunction

This study is looking at how a natural substance called resveratrol might help people with type 1 diabetes. Researchers want to see if taking 500 mg of oral trans-resveratrol twice a day for 12 weeks can improve how your body's endothelin-B receptor (a protein involved in blood vessel function) works and also improve the function of your muscle cells' powerhouses (mitochondria). They believe that increasing a protein called Sirtuin-1 with resveratrol could lead to these improvements. You may be able to join if you are an adult man or premenopausal woman with type 1 diabetes, and do not have certain other health conditions. The study aims to enroll 24 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive either resveratrol or a placebo. It plans to enroll 24 participants.
What's involved
Participants will take either resveratrol or a placebo twice daily for 12 weeks. Measurements will be taken at the beginning and after 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken at baseline and after 12 weeks of treatment.

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NCT04449198

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Augusta University
~24 participants
Updated 2025-01-28 on ClinicalTrials.gov
What's tested:ResveratrolPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in AUC for ET-1 + BQ-123
Measured over Measure taken at Baseline and post 12 weeks
+1 more outcome measured
Type 1 Diabetes
1 sites across 1 states
Georgia1

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Eligibility criteria

Inclusion

Men and premenopausal women
All races
Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

Exclusion

Clinical diagnosis of hepatic, cardiovascular, or renal disease
Uncontrolled diabetes (HbA1C \>12%)
Diabetic complications (i.e. neuropathy)
Uncontrolled hypertension (\>140/90 mm Hg on therapy)
Pregnancy
Use of vasoactive medications
  • Change in AUC for ET-1 + BQ-123Measure taken at Baseline and post 12 weeks

    Change in Area Under the Curve (AUC) for Cutaneous Vascular Conductance (CVC) in response to co-perfusion of ET-1 + BQ-123 at 12 weeks. Measured using intradermal microdialysis technique in conjunction with Laser Speckle Contrast Imaging (Moor FLPI-2) and beat-by-beat blood pressure monitoring (Finapres NOVA).

  • Skeletal Muscle Mitochondrial FunctionMeasure taken at Baseline and post 12 weeks

    Change in Skeletal Muscle Mitochondrial Function at 12 weeks. Measured using Near Infrared Spectroscopy (NIRS). Values are an index of phosphocreatine recovery expressed as a rate constant (min-1)