NCT04133922

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed description

The proposed study will determine the effect of GLP-1 infusion on microvascular perfusion and microvascular insulin responses in both skeletal and cardiac muscle microvasculature in humans with T1DM. The investigators will study 20 participants with T1DM using a state-of-the-art technology, contrast enhanced ultrasound (CEU), to assess whether GLP-1 augments skeletal and cardiac microvascular blood flow (MBF) as a representation of microvascular perfusion, flow-mediated dilation (FMD) as a measurement of endothelial function, and augmentation index (AI) and pulse wave velocity (PWV) as surrogates for large vessel compliance. The investigators will use the combined CEU and euglycemic-hyperinsulinemic clamp approach to determine if microvascular and metabolic IR improves as a result.

Conditions

• Type 1 Diabetes
• Insulin Sensitivity/Resistance

Interventions

Type	Name	Description
DRUG	GLP-1	glucagon-like peptide 1
DRUG	Insulin	we are using to replace basal insulin and to raise insulin concentrations during the insulin clamp
DRUG	Dextrose 20 % in Water	We are using Dextrose to maintain Euglycemia during the insulin clamp

Timeline

• Start date: 2019-10-14
• Primary completion: 2023-10-01
• Completion: 2024-10-01
• First posted: 2019-10-21
• Last updated: 2022-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study