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

Overview

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).

Full Title of Study: “Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2008

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.

Interventions

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

Arms, Groups and Cohorts

  • Other: PWS
  • Other: Controls

Clinical Trial Outcome Measures

Primary Measures

  • satiety hormones
    • Time Frame: 1 day

Secondary Measures

  • appetite (visual analogue scale) insulin secretion
    • Time Frame: 1 day

Participating in This Clinical Trial

Inclusion Criteria

  • see below Exclusion Criteria:

  • Diabetes mellitus, acute infections

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Garvan Institute of Medical Research
  • Overall Official(s)
    • Lesley V Campbell, Prof, Principal Investigator, Garvan Institute of Medical Research

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