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

NCT ID: NCT00551343

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-09-30

Brief Summary

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).

Detailed 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.

Conditions

Prader-Willi Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PWS

Group Type: OTHER

Exenatide

Intervention Type: DRUG

10ug Exenatide single s.c. injection

Controls

Group Type: OTHER

Exenatide

Intervention Type: DRUG

10ug Exenatide single s.c. injection

Interventions

Exenatide

10ug Exenatide single s.c. injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• see below

Exclusion Criteria

• Diabetes mellitus, acute infections

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Garvan Institute of Medical Research

OTHER

Sponsor Role: lead

Principal Investigators

Lesley V Campbell, Prof

Role: PRINCIPAL_INVESTIGATOR

Garvan Institute of Medical Research

Locations

Garvan Institute of Medical Research

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

X07-0178

Identifier Type: -

Identifier Source: secondary_id

H07/045

Identifier Type: -

Identifier Source: org_study_id