Prader-Willi Syndrome and Appetite - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175305

Purpose

Excessive weight gain is a cardinal feature of Prader-Willi syndrome (PWS) for which there is presently no effective treatment. It is caused by increased appetite, decreased perception of satiety and obsessive and compulsive behaviour towards food. Ghrelin is a powerful appetite-stimulating hormone. Patients with PWS have markedly elevated ghrelin levels, suggesting that it may be responsible for the increased food intake. The goal of the study is to determine whether treatment with somatostatin (Sandostatin), a hormone that inhibits ghrelin, is an effective treatment for the prevention and treatment of weight excess in patients with PWS.

Condition	Intervention	Phase
Hyperphagia Prader-Willi Syndrome	Drug: Sandostatin LAR	Phase III

Genetics Home Reference related topics: Prader-Willi syndrome

MedlinePlus related topics: Prader-Willi Syndrome

Drug Information available for: Octreotide Octreotide acetate Somatostatin Ghrelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Somatostatin on Ghrelin Concentrations, Food Seeking Behaviour and Weight in Patients With Prader-Willi Syndrome

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Changes in ghrelin concentrations during a test meal [ Time Frame: 8 to 10 AM ]

Secondary Outcome Measures:

Change in weight, behaviour and food intake

Estimated Enrollment:	10
Study Start Date:	August 2004
Study Completion Date:	October 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients with Prader-Willi syndrome, confirmed by genetic testing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175305

Locations

Canada, British Columbia
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Jean-Pierre Chanoine, MD

University of British Columbia

More Information

Study ID Numbers:	C04-0007, W04-0007
Study First Received:	September 9, 2005
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00175305
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Prader-Willi Syndrome
Somatostatin
Ghrelin

Obesity
Hyperphagia
Hyperphagia in Prader-Willi syndrome

Study placed in the following topic categories:

Chromosomal abnormalities
Obesity
Signs and Symptoms, Digestive
Chromosome Disorders
Octreotide
Prader-Willi syndrome
Somatostatin
Hyperphagia
Body Weight
Mental Retardation

Signs and Symptoms
Genetic Diseases, Inborn
Abnormalities, Multiple
Nutrition Disorders
Neurologic Manifestations
Overnutrition
Prader-Willi Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Pathologic Processes
Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Syndrome

Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009