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

Sponsored by:	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

Genetics Home Reference related topics: Prader-Willi syndrome

MedlinePlus related topics: Prader-Willi Syndrome

Drug Information available for: Exenatide Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.

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

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

Study placed in the following topic categories:

Chromosomal abnormalities
Obesity
Exenatide
Chromosome Disorders
Prader-Willi syndrome
Glucagon-Like Peptide 1
Mental Retardation
Genetic Diseases, Inborn

Abnormalities, Multiple
Neurologic Manifestations
Nutrition Disorders
Overnutrition
Prader-Willi Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Disease
Syndrome

Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009