Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes
Part of paid clinical trials in Charlottesville, Virginia.
- Sponsor
- University of Virginia
- Study ID
- NCT05478707
- Phase
- PHASE2
- Status
- Suspended
Conditions
- Diabetes Mellitus, Type 1
- Endothelial Dysfunction
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dulaglutide — DRUGGLP1-RA
- Placebo — DRUGSaline placebo
Study Details
The investigators will test the hypothesis that, in adults with type 1 diabetes (T1D), glucagon-like peptide-1 receptor agonism (GLP-1RA, i.e. dulaglutide) enhances insulin-mediated skeletal muscle microvascular perfusion via attenuating endothelial oxidative stress and thereby improving endothelial function.
Key Dates
- Start date
- Oct 5, 2023
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jul 30, 2028
Study Design
- Enrollment
- 47 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Placebo Comparator: PlaceboSaline subcutaneous injection, volume matched to dulaglutide, i.e. 0.5 mL weekly for 14 weeks
- Active Comparator: DulaglutideDulaglutide (0.75 mg/0.5 mL weekly for 2 weeks, then 1.5 mg/0.5 mL weekly for 12 weeks) subcutaneous injection
Primary Outcome Measure
Microvascular blood volume (MBV) [ Time Frame: At baseline and after 14 weeks of treatment. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | - |
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