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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00551343
Recruitment Status : Unknown
Verified October 2007 by Garvan Institute of Medical Research.
Recruitment status was:  Recruiting
First Posted : October 30, 2007
Last Update Posted : October 30, 2007
Information provided by:
Garvan Institute of Medical Research

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : October 2007
Estimated Study Completion Date : September 2008

Arm Intervention/treatment
PWS Drug: Exenatide
10ug Exenatide single s.c. injection

Controls Drug: Exenatide
10ug Exenatide single s.c. injection

Primary Outcome Measures :
  1. satiety hormones [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. appetite (visual analogue scale) insulin secretion [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • see below

Exclusion Criteria:

  • Diabetes mellitus, acute infections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00551343

Contact: Lisa Sze, MD ++61 2 9295 8214
Contact: Alex Viardot, MD ++61 2 9295 8310

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
Principal Investigator: Lesley V Campbell, Prof Garvan Institute of Medical Research Identifier: NCT00551343     History of Changes
Other Study ID Numbers: H07/045
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: October 30, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Prader-Willi Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Nutrition Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists