Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

GLP-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with T1DM, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Virginia
• Collaborators: American Diabetes Association; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Glucagon; Glucagon-Like Peptide 1; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. History of type 1 diabetes, duration > 1 year

2. Age 18-40 years

3. HbA1c < 8.5%

4. BMI >/=18, <30 kg/m2

5. Using insulin for diabetes treatment only

6. On stable regimen of non-diabetic medications for the last 6 months, excluding oral contraceptives (OCP)

7. All screening labs within normal limits or not clinical significant

Exclusion Criteria:

1) Pregnancy or currently breastfeeding 2) Smoking history within 6 months 3) History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) 4) Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers) 5) OCP use within 3 months or 1 month if menses has subsequently occurred 6) Known hypersensitivity to perflutren (contained in Definity© contrast) 7) Screening O2 saturation<90% 8) Anemia (hemoglobin <12 g/dL in women, hemoglobin <13 g/dL in men) 9) Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days

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