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

• Sponsor: Garvan Institute of Medical Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00551343
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prader-Willi Syndrome	Drug: Exenatide	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: PWS	Drug: Exenatide; 10ug Exenatide single s.c. injection
Other: Controls	Drug: Exenatide; 10ug Exenatide single s.c. injection

Outcome Measures

Primary Outcome Measures

1. satiety hormones [1 day]

Secondary Outcome Measures

1. appetite (visual analogue scale) insulin secretion [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• see below

Exclusion Criteria:

• Diabetes mellitus, acute infections

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Garvan Institute of Medical Research	Sydney	New South Wales	Australia	2010

Sponsors and Collaborators

• Garvan Institute of Medical Research

Investigators

• Principal Investigator: Lesley V Campbell, Prof, Garvan Institute of Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00551343
• Other Study ID Numbers: H07/045; X07-0178
• First Posted: Oct 30, 2007
• Last Update Posted: Jul 7, 2020
• Last Verified: Oct 1, 2007

• Additional relevant MeSH terms: Prader-Willi Syndrome; Syndrome; Exenatide

Study Results

No Results Posted as of Jul 7, 2020