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Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2010-023179-25-GB
Date of registration:	27/07/2011
Prospective Registration:	Yes
Primary sponsor:	Aintree University Hospital NHS Foundation Trust
Public title:	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
Scientific title:	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
Date of first enrolment:	13/09/2011
Target sample size:
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023179-25
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
United Kingdom

Contacts

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Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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: 14.0 Level: PT Classification code 10036476 Term: Prader-Willi syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: Byetta
Product Name: Byetta
Product Code: EU/1/06/362/003: 5µg (1 pen)
Pharmaceutical Form: Injection
INN or Proposed INN: exenatide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To investigate the effects of exenatide (a synthetic compound which is currently licensed and used as a treatment option in type 2 diabetes that has well described appetite supressing and weight-losing properties) on circulating ghrelin levels (a hormone produced by the stomach), appetite and food intake in subjects with PWS.

Primary end point(s): The primary outcome measure of our proposed study will be the effects of exenatide on circulating ghrelin levels, ghrelin isoforms, appetite rating and food intake in subjects with PWS.

Secondary Objective: We will also analyse the expression of adipokines (fat hormones) in subcutaneous adipose (fat) tissue, obtained by needle biopsy, in subjects with Prader Willi Syndrome compared to weight and adiposity-matched controls. This will allow us to explore possible links with the abnormal body composition and fat distribution observed in Prader Willi Syndrome subjects.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Secondary Sponsor(s)

UNIVERSITY OF LIVERPOOL

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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