Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 13 - 20 |
| Updated: | 7/16/2013 |
| Start Date: | March 2012 |
| End Date: | July 2013 |
| Contact: | Parisa Salehi, MD |
| Email: | psalehi@chla.usc.edu |
| Phone: | 323-361-8816 |
Effects of Exenatide on Obesity and Appetite in Overweight Patients With Prader-Willi Syndrome
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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