Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes

What Was Tested

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

If they fulfill the inclusion and none of the exclusion criteria, they will be, after signing informed consent, randomized to a six-month intervention with either pioglitazone, empagliflozin or semaglutide.

Fat biopsies are obtained from the subcutaneous abdominal area before and after a hyperinsulinemic-euglycemic clamp at baseline and after six months.

It had three arms (groups): Pioglitazone (active comparator), Empagliflozin (experimental) and Semaglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

A detailed description of the protocol has been approved by the Swedish Medical Products Agency and the study is registered as EudraCT: 2021-002367-21.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Signed informed consent. BMI 25 kg/m2 or higher.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: established cardiovascular disease and/or heart failure; severe psychiatric condition; active alcoholism.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2023-02-08 with completion listed for 2026-09-01.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in fat cell lipolysis after 6 months of treatment (time frame: Baseline and after six months intervention).

It also tracked 1 secondary outcome, for example Changes in fat cell heterogeneity after 6 months of treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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