Effects of exenatide on appetite and ghrelin levels in patients with Prader-Willi Syndrome - Effects of exenatide on appetite and ghrelin in Prader-Willi Syndrome

• Conditions: Ghrelin levels in patients with Prader Willi Syndrome and healthy controls and response of ghrelin levels to a single exenatide injection compared with placebo (0.9% sodium chloride) injection.; MedDRA version: 14.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders

• Registration Number: EUCTR2010-023179-25-GB
• Lead Sponsor: Aintree University Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with Prader-Willi Syndrome with inadequately controlled body weight (BMI > 25 kg/m2), and healthy volunteers (without diabetes), matched for age and adiposity.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

For the Prader Willi Syndrome group: patients with Prader Willi Syndrome with adequately controlled body weight (BMI < 25 kg/m2) will be excluded for safety reasons (see above). Also patients with type 1 or 2 diabetes mellitus will be excluded. Exclusion criteria for control participants have been chosen because they will have a direct influence on eating behaviour and patterns. Participants with the following will be excluded: a history of eating disorder such as bulimia nervosa, anorexia nervosa or binge-eating disorder (according to DSM IV criteria), history of psychiatric disorder (schizophrenia, major depression, bipolar affective disorder), diabetes mellitus (type 1 or 2), current history of excess alcohol consumption or substance abuse or addiction, current (or within last 3 months) use of certain centrally acting medication (certain psychotropic or antidepressant medications) that are known to influence feeding behaviour, a history of traumatic brain injury, genetic forms of hypothalamic obesity (such as Prader-Willi syndrome, Biedl-Bardet syndrome). For all participants: the presence of metal implants or metal objects on the body which cannot be removed (those fitted with a heart pacemaker, mini-defibrillator or neurostimulator or have an artificial heart valve; surgical clips in the head; history of injury which may have left metal particles in the eye, head, or elsewhere in the body) will be excluded from the abdominal MRI aspect of the study, as these factors would pose a safety risk to the participant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified