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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2007 by Garvan Institute of Medical Research. Recruitment status was Recruiting

First Received on October 29, 2007. No Changes Posted

Sponsor:	Garvan Institute of Medical Research
Information provided by:	Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:	NCT00551343

Purpose

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	Intervention
Prader-Willi Syndrome	Drug: Exenatide

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome Prader-Willi syndrome tetrasomy 18p

MedlinePlus related topics: Diabetes Medicines Prader-Willi Syndrome

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by Garvan Institute of Medical Research:

Primary Outcome Measures:

satiety hormones [ Time Frame: 1 day ]

Secondary Outcome Measures:

appetite (visual analogue scale) insulin secretion [ Time Frame: 1 day ]

Estimated Enrollment:	20
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008

Arms	Assigned Interventions
PWS	Drug: Exenatide 10ug Exenatide single s.c. injection
Controls	Drug: Exenatide 10ug Exenatide single s.c. injection

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

see below

Exclusion Criteria:

Diabetes mellitus, acute infections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551343

Contacts

Contact: Lisa Sze, MD	++61 2 9295 8214	l.sze@garvan.org.au
Contact: Alex Viardot, MD	++61 2 9295 8310	a.viardot@garvan.org.au

Locations

Australia, New South Wales
Garvan Institute of Medical Research	Recruiting
Darlinghurst 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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00551343 History of Changes
Other Study ID Numbers:	H07/045, X07-0178
Study First Received:	October 29, 2007
Last Updated:	October 29, 2007
Health Authority:	Australia: Human Research Ethics Committee

Additional relevant MeSH terms:

Prader-Willi Syndrome
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders

Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012