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Clinical trial

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

ID
Name
1595933
Description
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.
Trial arms
Trial start
2020-10-14
Estimated PCD
2025-01-01
Trial end
2025-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Resveratrol
500 mg of oral trans-resveratrol twice daily (in the morning and evening) for 12-weeks
Arms:
Individuals with type 1 diabetes
Placebo
placebo for 12 weeks
Arms:
Individuals with type 1 diabetes
Size
24
Primary endpoint
Change in AUC for ET-1 + BQ-123
Measure taken at Baseline and post 12 weeks
Skeletal Muscle Mitochondrial Function
Measure taken at Baseline and post 12 weeks
Eligibility criteria
Inclusion Criteria: * Men and premenopausal women * All races * Clinical diagnosis of insulin-dependent type 1 diabetes (patients only) Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2023-07-20

1 organization

1 product

1 indication

Organization
Augusta University
Product
Resveratrol
Indication
Type 1 Diabetes