| Trial ID: | L7077 |
| Source ID: | NCT04449198
|
| Associated Drug: |
Resveratrol
|
| Title: |
Type 1 Diabetes, Endothelin, and Skeletal Muscle Mitochondrial Dysfunction: The Role of Sirtuin-1
|
| Acronym: |
T-St1M
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Resveratrol|OTHER: Placebo
|
| Outcome Measures: |
Primary: 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)., Measure taken at Baseline and post 12 weeks|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), Measure taken at Baseline and post 12 weeks | Secondary: 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 %, Measure taken at Baseline and post 12 weeks|Change in Pulse Wave Velocity (PWV), Change in PWV at 12 weeks. Measured by Shygmocor Xcel in m/s., Measure taken at Baseline and post 12 weeks|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., Baseline and post 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Augusta University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-10-14
|
| Completion Date: |
2027-07-01
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-28
|
| Locations: |
Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology, Augusta, Georgia, 30912, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04449198
|
