Back to resultsGut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
Primary Purpose
Prader-Willi Syndrome
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Prader-Willi Syndrome
Eligibility Criteria
Inclusion Criteria:
- see below
Exclusion Criteria:
- Diabetes mellitus, acute infections
Sites / Locations
- Garvan Institute of Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PWS
Controls
Arm Description
Outcomes
Primary Outcome Measures
satiety hormones
Secondary Outcome Measures
appetite (visual analogue scale) insulin secretion
Full Information
NCT ID
NCT00551343
First Posted
October 29, 2007
Last Updated
July 3, 2020
Sponsor
Garvan Institute of Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT00551343
Brief Title
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
Official Title
Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Garvan Institute of Medical Research
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PWS
Arm Type
Other
Arm Title
Controls
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
10ug Exenatide single s.c. injection
Primary Outcome Measure Information:
Title
satiety hormones
Time Frame
1 day
Secondary Outcome Measure Information:
Title
appetite (visual analogue scale) insulin secretion
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
see below
Exclusion Criteria:
Diabetes mellitus, acute infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley V Campbell, Prof
Organizational Affiliation
Garvan Institute of Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Garvan Institute of Medical Research
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
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