Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Part of paid clinical trials in Orlando, Florida.

Sponsor: AdventHealth Translational Research Institute
Study ID: NCT05478707
Phase: PHASE2
Status: Recruiting

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Conditions

Diabetes Mellitus, Type 1
Endothelial Dysfunction

Eligibility Criteria

Sex: ALL
Age: 18 Years - 40 Years
Healthy Volunteers: Not accepted

Interventions

Dulaglutide — DRUG
GLP1-RA
Placebo — DRUG
Saline 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

First listed: Jul 28, 2022
Start date: Oct 5, 2023
Status verified: Aug 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: Placebo
Saline subcutaneous injection, volume matched to dulaglutide, i.e. 0.5 mL weekly for 14 weeks
Active Comparator: Dulaglutide
Dulaglutide (0.75 mg/0.5 mL weekly for 2 weeks, then 1.5 mg/0.5 mL weekly for 12 weeks) subcutaneous injection