Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome

Completed · Not applicable

Conditions studied: Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT01444898

Run by

Children's Hospital Los Angeles

People needed

10

Starts

2012-03-01

Expected to finish

2013-12-01

Last updated by the study team

2016-09-29

Who can join

Age: 13 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Prader Willi Syndrome confirmed by genetic testing (DNA methylation or FISH)
• Ages 13-20 years
• body mass index (BMI) > 85th percentile for age and gender

You may not qualify if…

• Is currently using or has previously used a glucagon-like peptide-1 (GLP-1) agonist
• History of pancreatitis, or renal failure
• History of familial pancreatitis
• Amylase, or lipase levels > 2.5 times the upper limit of normal any time in the previous 2 years
• Creatinine clearance < 30 mL/min
• Other syndromic diagnoses
• gastrointestinal (GI) or renal illness in the 1 month prior to entering study
• Inability to take study drug
• Pregnancy
• Initiation of growth hormone (GH), estrogen, or testosterone or change > 25% of dose/kg/day during the 6 months prior to starting study
• Non-English speaking

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.