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

ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAugusta University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men and premenopausal women

All races

Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resveratrol

    Drug

    500 mg of oral trans-resveratrol twice daily (in the morning and evening) for 12-weeks

  • Placebo

    Other intervention

    placebo for 12 weeks

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Individuals with type 1 diabetesExperimental treatment 2 interventions
Group B: Healthy ControlsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in AUC for ET-1 + BQ-123

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).

Time frame
Measure taken at Baseline and post 12 weeks
2

Skeletal Muscle Mitochondrial Function

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)

Time frame
Measure taken at Baseline and post 12 weeks

Secondary outcomes

1

Change in Percentage Flow-Mediated Dilation (FMD)

Change in Percentage FMD at 12 weeks. Measured via ultrasound in conjunction with edge detection software. Expressed as %

Time frame
Measure taken at Baseline and post 12 weeks
2

Change in Pulse Wave Velocity (PWV)

Change in PWV at 12 weeks. Measured by Shygmocor Xcel in m/s.

Time frame
Measure taken at Baseline and post 12 weeks
3

Change in Post Occlusive Reactive Hyperemia (PORH)

Change in PORH at 12 weeks. Measured by Laser Speckle Contrast Imager (Moor FLPI-2) in perfusion units (PU). Represents the maximal dilatory response in the microcirculation post 5 minute occlusion.

Time frame
Baseline and post 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Augusta University

Lead sponsor

Source ClinicalTrials.gov
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