The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

The aim of this study is to evaluate the effect of glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide on disordered eating behaviour in patients with overweight and type 2 diabetes.

The investigators will also evaluate serum concentrations of incretin hormones GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), as well as glucose variability using continuous glucose monitoring (CGM) devices before and after semaglutide, and determine his influence on eating disorders.

In this prospective study the investigators aim to recruit 60 patients with type 2 diabetes and randomize them based on the presence of a disordered eating behaviour diagnosed by a validated questionnaire (1:1).

It had three arms (groups): Type 2 diabetic patients without disordered eating behaviour (placebo comparator), Type 2 diabetic patients with disordered eating behaviour A (placebo comparator) and Type 2 diabetic patients with disordered eating behaviour B (experimental).

Treated with standard of care.

Treated with standard of care.

Receiving semaglutide for 12 weeks.

The registry classes the interventions as drug.

More on the Plan

Patients will be randomized after completing the EAT-26 questionnaire (1:1), in group with disordered eating behaviour (n=30) if participants scored \>20 points, and group without disordered eating behaviour (n=30) if participants scored ≤20 points.

Group of patients with disordered eating behaviour will be further randomized whether participants will receive semaglutide (n=15) with standard care or if participants will be treated with standard care (n=15).

HDL, LDL, triglyceride), C reactive protein (CRP), urine sediment and their changes at the end of the trial (except mixed meal test).

A factor analysis of EAT-26 scores will be conducted to form 3 (expected) latent variables (components).

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2024-02-01 with completion listed for 2024-12-31.

It ran at 1 site in Croatia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Eating Attitude Test (EAT-26) questionnaire score (time frame: EAT-26 questionnaire will be assessed at the beginning of the trial and at the end of the trial after 12 weeks).

It also tracked 2 secondary outcomes, for example Continuous glucose monitoring parameter (Glycemic Variability) and Concentration of incretin hormones (GLP-1, GIP).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 60 people.

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.