Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults

What Was Tested

In this early phase 1 trial, researchers set out to test Insulin (regular human) and Octreotide.

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

It had four arms (groups): Octreotide- Euglycemia (active comparator), Octreotide - Euglycemia- insulin clamp (active comparator), Octreotide- hyperglycemia (active comparator) and Octreotide- hyperglycemia - insulin clamp (active comparator).

The registry classes the interventions as drug.

More on the Plan

The investigators will study 22 healthy subjects (18-35 yrs) four times as follows: 1.

Saline + Octreotide + euglycemia; 2.

Octreotide + hyperglycemia + insulin clamp and 4.

Octreotide + Euglycemia + insulin clamp.

Who Took Part

The registry lists 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy with no chronic illness. Normal BMI (18-25).

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: smoking presently or in the past 6 months; medications that affect the vasculature; overweight or other indications of insulin resistance.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2019-02-04 with completion listed for 2021-04-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp (time frame: baseline and after 2 hour insulin clamp).

It also tracked 2 secondary outcomes, for example Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp and Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) and Octreotide in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Octreotide compound page, all human trials.