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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Garvan Institute of Medical Research.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00551343
First Posted: October 30, 2007
Last Update Posted: October 30, 2007
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.
Information provided by:
Garvan Institute of Medical Research
  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
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.

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • see below

Exclusion Criteria:

  • Diabetes mellitus, acute infections
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00551343     History of Changes
Other Study ID Numbers: H07/045
X07-0178
First Submitted: October 29, 2007
First Posted: October 30, 2007
Last Update Posted: October 30, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists