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NCT00551343 Clinical Trial

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

Prader-Willi Syndrome Clinical Trial

Official title:
Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00551343
Other study ID # H07/045
Secondary ID X07-0178
Status Completed
Phase N/A
First received
Last updated
Start date October 2007
Est. completion date September 2008

Study information
Verified date October 2007
Source Garvan Institute of Medical Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- see below

Exclusion Criteria:

- Diabetes mellitus, acute infections

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Australia Garvan Institute of Medical Research Sydney New South Wales

Sponsors (1)
Lead Sponsor Collaborator
Garvan Institute of Medical Research

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary satiety hormones 1 day
Secondary appetite (visual analogue scale) insulin secretion 1 day
See also
  Status Clinical Trial Phase
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Completed NCT04526379 - Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation N/A
Terminated NCT03458416 - A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome Phase 2
Completed NCT03718416 - Natural History Study of Serious Medical Events in PWS
Active, not recruiting NCT05322096 - Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome Phase 2
Terminated NCT02179151 - Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome Phase 3
Completed NCT02205450 - Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell
Completed NCT00375089 - Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity N/A
Completed NCT00004351 - Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes N/A
Recruiting NCT05938543 - Cerebellar TMS and Satiety in Prader-Willi Syndrome N/A
Recruiting NCT05879614 - An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001) Phase 2
Recruiting NCT03031626 - Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome Phase 4
Withdrawn NCT04086810 - An Open-Label Study of DCCR Tablet in Patients With PWS Phase 3
Completed NCT02629991 - Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome Phase 2
Recruiting NCT02297022 - Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome Phase 1
Not yet recruiting NCT02263781 - PREPL in Health and Disease N/A
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Recruiting NCT05939453 - Impact of Bright Light Therapy on Prader-Willi Syndrome N/A
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Completed NCT03714373 - Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period Phase 3