Exercise and GLP-1 RA on Insulin Secretion

What Was Tested

In this not phased trial, researchers set out to test Semaglutide.

The purpose of this study is to determine the effect of endurance exercise on insulin secretory capacity, alone or in addition to treatment with the glucagon-like-peptide receptor agonist semaglutide, in patients with type 2 diabetes.

It had three arms (groups): Semaglutide treatment (experimental), Semaglutide and Endurance exercise (experimental) and Endurance exercise (experimental).

3 months of therapeutic semaglutide treatment.

12 weeks of endurance exercise concomitant to semaglutide treatment.

12 weeks of endurance exercise.

The registry classes the interventions as behavioral and drug.

More on the Plan

The effects of endurance exercise alone or in addition to treatment with glucagon-like- peptide receptor agonists on insulin secretory capacity, will be determined in patients with type 2 diabetes.

Included patients will be randomized to either 12 weeks of endurance exercise training 3 times a week or therapeutical treatment with semaglutide for 3 months followed by 12 weeks of endurance exercise training 3 times a week.

Insulin secretory capacity will be determined by hyperglycemic clamp method before and after.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 40 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed with type 2 diabetes. Moderately preserved insulin secretory capacity (determined by glucagon test).

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: insulin treatment; hypertension grade 3; heart disease.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2019-12-10 with completion listed for 2021-08.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Insulin secretion (time frame: Change from baseline insulin secretion after Exercise intervention(12 weeks)). Insulin secretion (time frame: Change from baseline insulin secretion after 3 months of therapeutic semaglutide treatment). Insulin secretion (time frame: Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment).

It also tracked 6 secondary outcomes, for example Insulin secretion, insulin sensitivity, Changes in plasma bone markers, Glucose homeostasis, Cardiorespiratory fitness and Body composition.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 30 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.