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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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21 December 2015 |
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Main ID: |
NCT01542242 |
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Date of registration:
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21/02/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Liraglutide Use in Prader-Willi Syndrome
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Scientific title:
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Date of first enrolment:
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February 2012 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01542242 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jason Kong, MD, FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vancouver General Hospital, University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Prader Willi Syndrome, Diabetes Type 2
Exclusion Criteria:
- Previous or family history of Medullary Carcinoma of the Thyroid or multiple
endocrine neoplasia syndrome.
- Subjects with acute or chronic Pancreatitis
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus Type 2
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Prader Willi Syndrome
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Intervention(s)
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Drug: Liraglutide
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Primary Outcome(s)
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Hemoglobin A1C
[Time Frame: Change from baseline in A1C at 12 months]
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Secondary Outcome(s)
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Hip Circumference (cm)
[Time Frame: Change from baseline in hip circumference at 12 months]
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Fasting Lipid Profile
[Time Frame: Change from baseline in fasting lipid profile at 12 months]
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Body Weight (kg)
[Time Frame: Change from baseline in body weight at 12 months]
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Fasting Blood Glucose (mmol/L)
[Time Frame: Change from baseline in fasting blood glucose at 12 months]
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Total Body Adipose Tissue Distribution (whole body Computed Tomography)
[Time Frame: Change from baseline in total body adipose tissue distribution at 12 months]
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Fasting Blood Insulin level
[Time Frame: Change from baseline in fasting blood insulin at 12 months]
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Secondary ID(s)
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PWS.VGH.UBC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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