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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01444898 |
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Date of registration:
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27/09/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome
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Scientific title:
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Effects of Exenatide on Obesity and Appetite in Overweight Patients With Prader-Willi Syndrome |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01444898 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Debra Jeandron, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Los Angeles |
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Key inclusion & exclusion criteria
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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
Age minimum:
13 Years
Age maximum:
20 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Intervention(s)
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Drug: Exenatide
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Primary Outcome(s)
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Appetite Scores
[Time Frame: 6 months]
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Change in Weight
[Time Frame: 6 months]
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Change in BMI Z-Score
[Time Frame: 6 months]
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Change in HbA1c (%)
[Time Frame: 6 months]
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Change in Insulin Levels
[Time Frame: 6 months]
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Change in Acy Ghr
[Time Frame: 6 months]
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Change in Pancreatic Peptide (PP)
[Time Frame: 6 months]
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Change in Leptin
[Time Frame: 6 months]
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% Change in Body Mass Index (BMI)
[Time Frame: 6 months]
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Secondary ID(s)
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CCI 11-00227
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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