Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes

What Was Tested

The trial (early phase 1) is built around Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

It had three arms (groups): GLP-1 (active comparator), GLP-1 + Insulin clamp (active comparator) and Saline + Insulin clamp (active comparator).

The registry classes the interventions as drug.

More on the Plan

The proposed study will determine the effect of GLP-1 infusion on microvascular perfusion and microvascular insulin responses in both skeletal and cardiac muscle microvasculature in humans with T1DM.

Who Took Part

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Age 18-40 years. BMI \>/=18, \<30 kg/m2. On stable regimen of non-diabetic medications for the last 6 months, excluding oral contraceptives (OCP).

The full record lists 7 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-10-14 with completion listed for 2023-10.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: change in microvascular blood volume between baseline and 2 hour insulin clamp (time frame: baseline and after 2 hour insulin clamp). change in insulin sensitivity between baseline and 2 hour insulin clamp (time frame: baseline and after 2 hour insulin clamp).

It also tracked 3 secondary outcomes, for example change in augmentation index between baseline and 2 hour insulin clamp, change in flow-mediated dilation between baseline and 2 hour insulin clamp and change in pulse wave velocity between baseline and 2 hour insulin clamp.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) in people with insulin resistance, prediabetes & type 2 diabetes.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.