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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00551343




Registration number
NCT00551343
Ethics application status
Date submitted
29/10/2007
Date registered
30/10/2007
Date last updated
30/10/2007

Titles & IDs
Public title
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
Scientific title
Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.
Secondary ID [1] 0 0
X07-0178
Secondary ID [2] 0 0
H07/045
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prader-Willi Syndrome 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Mental Health 0 0 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Exenatide

Other: PWS -

Other: Controls -


Treatment: Drugs: Exenatide
10ug Exenatide single s.c. injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
satiety hormones
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
appetite (visual analogue scale) insulin secretion
Timepoint [1] 0 0
1 day

Eligibility
Key inclusion criteria
- see below
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Diabetes mellitus, acute infections

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Garvan Institute of Medical Research - Darlinghurst Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT00551343
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lesley V Campbell, Prof
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Sze, MD
Address 0 0
Country 0 0
Phone 0 0
++61 2 9295 8214
Fax 0 0
Email 0 0
l.sze@garvan.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00551343