Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Trial ID: NCT05478707

Interventional - Phase 2 - Recruiting

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.

Conditions

• Diabetes Mellitus, Type 1
• Endothelial Dysfunction

Interventions

• Dulaglutide
• Placebo

Eligibility

Inclusion criteria

• History of type 1 diabetes, duration \> 5 years
• Age 18-40 years
• HbA1c \< 8.5%
• BMI 19-34.9 kg/m2
• Using insulin for diabetes treatment only (multiple daily injections or insulin pump with or without sensor augmentation)
• On stable regimen of non-diabetic medications for the last 6 months
• All screening labs within normal limits or not clinically significant - English or Spanish speaking

Exclusion criteria

• Pregnancy or currently breastfeeding
• Smoking history within 6 months
• History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) as well as clinically significant cardiac arrhythmias or conduction disorders
• Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers).
• Known hypersensitivity to perflutren (contained in Definity© contrast)
• Screening O2 saturation \<90%
• Musculoskeletal condition preventing participation in exercise testing or exercise training
• Acute or unstable disease other than T1D
• Hypoglycemia unawareness
• History of gastroparesis, severe gastroesophageal reflux, pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
• Anemia (hemoglobin \<12 g/dL in women, hemoglobin \<13 g/dL in men), eosinophilia (absolute eosinophil count \>500 cells/microliter) leukopenia (total white blood cells \<4,000 cells/microliter)
• Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days
• Hospital admission for DKA within 1 year

Sponsor

AdventHealth Translational Research Institute

Source: ClinicalTrials.gov

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