Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a
major source of morbidity and mortality in this population. It can lead to sleep apnea, cor
pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set
it apart from other forms of obesity including insatiable appetite and food-seeking behavior
which can be disruptive to home and school activities, and can cause severe social and
psychological turmoil within families. PWS is also associated with unique hormonal
abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the
stomach that stimulates food intake during a fast. It is hypothesized that the extremely high
ghrelin levels in patients with PWS may cause or contribute to their insatiable appetite.
Exenatide, a medication used in the treatment of type 2 diabetes mellitus in adults, appears
to suppress ghrelin levels and cause weight loss. It was designed to mimic glucagon-like
peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and delays gastric
emptying, among other effects. In the present study, the investigators will investigate the
effects of a 6 month trial of exenatide in overweight adolescents with PWS. The investigators
will quantify the changes in weight and body composition, as well as subjective measures of
appetite, and concentrations of appetite-associated hormones. The investigators hypothesize
that exenatide will improve weight, body composition, appetite, and plasma ghrelin levels
during the treatment period.