Status:
WITHDRAWN
Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
American Diabetes Association
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Insulin Sensitivity/Resistance
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
Brief 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 fu...
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. ...
Eligibility Criteria
Inclusion
- History of type 1 diabetes, duration \> 1 year
- Age 18-40 years
- HbA1c \< 8.5%
- BMI \>/=18, \<30 kg/m2
- Using insulin for diabetes treatment only
- On stable regimen of non-diabetic medications for the last 6 months, excluding oral contraceptives (OCP)
- All screening labs within normal limits or not clinical significant
Exclusion
- 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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Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04133922
Start Date
October 14 2019
End Date
October 1 2024
Last Update
March 22 2022
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22906