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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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9 January 2017 |
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Main ID: |
NCT03002675 |
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Date of registration:
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15/12/2016 |
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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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Exenatide and Brown Adipose Tissue
exe01 |
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Scientific title:
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The Effect of Exenatide on Brown Adipose Tissue Activity and Energy Expenditure in Healthy Young Men |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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24 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03002675 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: 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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Netherlands
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Contacts
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Name:
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Ingrid Jazet, MD, PhD |
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Address:
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Telephone:
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+33-715268161 |
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Email:
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i.m.jazet@lumc.nl |
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Affiliation:
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Name:
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Ingrid Jazet Jazet, MD |
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Address:
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Telephone:
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Email:
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i.m.jazet@lumc.nl |
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Affiliation:
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Name:
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Ingrid Jazet, 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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Leiden University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Dutch South Asian or white Caucasian male, 20-30 years
- BMI = 18 and = 25 kg/m2
- Good general health
Exclusion Criteria:
- BMI > 25 kg/m2 or < 18 kg/m2
- Use of medication known to influence glucose and/or lipid metabolism or brown fat
activity (e.g. beta blockers)
- Any significant chronic disease
- Renal, hepatic or endocrine disease
- Smoking
- Participation in an intensive weight-loss program or vigorous exercise program during
the last year before the start of the study
- Recent participation in other research projects (within the last 3 months),
participation in 2 or more projects in one year
- Contraindications for undergoing an MRI scan:
- Presence of non-MR safe metal implants or objects in the body.
- Pacemaker, neurostimulator, hydrocephalus pump, drug pump, non-removable hearing aid,
large recent tattoos.
- Claustrophobia
- Tinnitus or hyperacusis
Age minimum:
20 Years
Age maximum:
30 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Drug: Bydureon
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Primary Outcome(s)
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The effect of exenatide on BAT activity and energy expenditure in healthy young South Asian compared to white Caucasian men
[Time Frame: End of the study, up to 21 months]
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Secondary Outcome(s)
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Visualisation of BAT as measured with MRI scan compared to FDG-PET CT
[Time Frame: End of the study, up to 21 months]
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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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