NCT03520569

Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vascular Stiffness
• Insulin Sensitivity

Interventions

Type	Name	Description
DRUG	Octreotide	we are using it to block insulin secretion from the pancreas
DRUG	Insulin	we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
DRUG	Dextrose 20% solution	We are using dextrose to maintain glycemia level

Timeline

• Start date: 2019-02-04
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2018-05-09
• Last updated: 2022-05-13
• Results posted: 2022-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study