Insulin Sensitivity Clinical Trial
— EJB050Official title:
Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults
Verified date | April 2022 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults
Status | Completed |
Enrollment | 15 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Healthy with no chronic illness - Age 18-35 - Normal BMI (18-25) - Normal screening labs or no clinically significant values Exclusion Criteria: - First degree relative with Type 2 Diabetes - Smoking presently or in the past 6 months - Medications that affect the vasculature - Overweight or other indications of insulin resistance - Elevated LDL cholesterol > 160 - Elevated BP > 140/90 - History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease, bleeding disorders - Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease - Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI). - Pregnant or breastfeeding. - Known hypersensitivity to perflutren (contained in Definity) |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp | Flow mediated dilation measures the change in brachial diameter in response to 5 minutes of ischemia using B-mode ultrasound. It provides an index of nitric oxide generation by the endothelium . | baseline and after 2 hour insulin clamp | |
Secondary | Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp | The augmentation index (AIx) measured at the radial artery is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (? P) to central pulse pressure and expressed as percent. AIx = (?P/PP) x 100, where P = pressure and PP = Pulse Pressure. Higher percentages indicate increased arterial stiffness. | baseline and after 2 hour insulin clamp | |
Secondary | Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp | The time required for a blood pressure wave to travel from the carotid to the femoral artery was measured in meter/sec. This is a measurement of central artery stiffness. Higher numbers indicate stiffer vessels | baseline and after 2 hour insulin clamp |
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