Status:
COMPLETED
Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
13-20 years
Phase:
NA
Brief 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, dia...
Detailed Description
BACKGROUND: Prader-Willi syndrome (PWS) is associated with hyperphagia and hyperghrelinemia with major morbidity because of obesity without effective medical treatment targeting hyperphagia. Exenatid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01444898
Start Date
March 1 2012
End Date
December 1 2013
Last Update
September 29 2016
Active Locations (1)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027