Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome

What Was Tested

The trial (not phased) is built around Exenatide.

The purpose of this study is to investigate the effects of a GLP-1 agonist on satiety hormones in patients with Prader-Willi Syndrome (genetic defect causing obesity).

It had two arms (groups): PWS (other) and Controls (other).

The registry classes the interventions as drug.

More on the Plan

Prader-Willi Syndrome (PWS) is the most frequent known genetic disorder of obesity.

The emerging costs for professional care are immense.

The aim of this pilot drug trial is to analyse the effect of a GLP-1 agonist on appetite regulating hormones, insulin secretion and energy expenditure before and after a meal.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: diabetes mellitus, acute infections.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and investigator.

It started in 2007-10 with completion listed for 2008-09.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: satiety hormones (time frame: 1 day).

It also tracked 1 secondary outcome, for example appetite (visual analogue scale) insulin secretion.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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