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

Garvan Institute of Medical Research

Status: Completed

Conditions: Prader-Willi Syndrome

Treatments: Drug: Exenatide

Study type: Interventional

Funder types: Other

Identifiers

NCT00551343

H07/045

X07-0178

Details and patient eligibility

About

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).

Full description

Prader-Willi Syndrome (PWS) is the most frequent known genetic disorder of obesity. Hyperphagia is the main barrier to independent living in adults with PWS, and hitherto behavioural restraints and environmental modification are the only effective management measure. The emerging costs for professional care are immense. Thus, there is an urgent need for treatment which reduce appetite and food intake in this patient group. Agonists of the gut derived hormone GLP-1 which reduces food intake and causes weight loss due to slowed gastric emptying and through direct central effects. 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• see below

Exclusion criteria

• Diabetes mellitus, acute infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

PWS

Other group

Treatment:

Drug: Exenatide

Controls

Other group

Treatment:

Drug: Exenatide