An Early Phase 1 interventional study of GLP-1 and Insulin in Type 1 Diabetes and Insulin Sensitivity/Resistance, sponsored by University of Virginia. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by University of Virginia · Early Phase 1, Interventional, and Basic science
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
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
Browse Diabetes Mellitus studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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GLP-1 infusion 1.2 pmol/kg/min for 150 min
Drug: GLP-1
GLP-1 infusion 1.2 pmol/kg/min for 150 min and insulin 1 mU/kg/min + Dextrose 20% at variable rate to maintain euglycemia for 120 min
Drug: GLP-1 · Drug: Insulin · Drug: Dextrose 20 % in Water
Saline infusion at 30 ml/hr for 150 min and insulin 1 mU/kg/min + Dextrose 20% at variable rate to maintain euglycemia for 120 min.
Drug: Insulin · Drug: Dextrose 20 % in Water
glucagon-like peptide 1
we are using to replace basal insulin and to raise insulin concentrations during the insulin clamp
We are using Dextrose to maintain Euglycemia during the insulin clamp
change in microvascular blood volume between baseline and 2 hour insulin clamp
vascular measurement
Time frame: baseline and after 2 hour insulin clamp
change in insulin sensitivity between baseline and 2 hour insulin clamp
vascular measurement
Time frame: baseline and after 2 hour insulin clamp
change in augmentation index between baseline and 2 hour insulin clamp
vascular measurement
Time frame: baseline and after 2 hour insulin clamp
change in flow-mediated dilation between baseline and 2 hour insulin clamp
vascular measurement
Time frame: baseline and after 2 hour insulin clamp
change in pulse wave velocity between baseline and 2 hour insulin clamp
vascular measurement
Time frame: baseline and after 2 hour insulin clamp
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of Virginia