Early Phase 1 N=15 Randomized Basic Science

Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults

Vascular Stiffness · Insulin Sensitivity

Bottom Line

View on ClinicalTrials.gov: NCT03520569 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp — 11.8; 11.8; 8.9; 8.95 % change

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Octreotide (Drug); Insulin (Drug); Dextrose 20% solution (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Virginia
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp	11.8; 11.8; 8.9; 8.95	—
SECONDARY Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp	-4.15; -2.23; -4.80; -8.45	—
SECONDARY Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp	5.21; 5.06; 4.79; 5.07	—

Summary

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

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03520569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.