Clinical trial NCT03520569: Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults
Official title: Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vascular Stiffness
Insulin Sensitivity
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-05-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject is studied 4 times in a randomized sequential order
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults

Detailed description: The investigators will study 22 healthy subjects (18-35 yrs) four times as follows:

1. Saline + Octreotide + euglycemia;
2. Octreotide + hyperglycemia;
3. Octreotide + hyperglycemia + insulin clamp and
4. Octreotide + Euglycemia + insulin clamp.

The sequence of admissions will be assigned randomly. The investigators will assess function in conduit (pulse wave velocity-PWV, augmentation index-AI and flow-mediated dilation-FMD), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels.

This work will:

a) identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree with hyperglycemia.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp
timeFrame: baseline and after 2 hour insulin clamp
Secondary outcomes:
measure: Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp
timeFrame: baseline and after 2 hour insulin clamp
measure: Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp
timeFrame: baseline and after 2 hour insulin clamp
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
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