An interventional study of Bromocriptine in Obesity, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-29.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable and Interventional
In this study the investigators will investigate the effect of dopamine (bromocriptine) on Brown Adipose Tissue in lean, young, healthy males.
The investigators will also examine energy expenditure, body temperature and insulin sensitivity as measurements of Brown Adipose Tissue activity.
In this study the investigators will investigate whether bromocriptine influences the metabolic activity of BAT, as assessed with a 18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET)-CT scan
This is an observational, prospective design with invasive measurements. The investigators will include 16 healthy lean male volunteers (aged 18-30 years, BMI 19-25 kg/m2) The volunteers will be recruited by advertisement in local paper and internet (via social media), covering the direct surroundings of our clinic (Amsterdam) and by advertisement at the medical faculty of the Academic Medical Center (AMC).
The included subjects will visit the AMC hospital on 3 occasions. During visit 1 the investigators will obtain the Informed consent after oral and written information about the study. The investigators will obtain a medical history, vital signs and laboratory measurements.
During visit 2 the investigators will measure body weight and the investigators will perform an energy expenditure measurement after 40 minutes of bed rest. The investigators will regularly measure temperature by a tympanic thermometer. The subjects will receive intravenous administration of the radioactive pharmacon 18F-FDG, 60 minutes after the administration of the 18F-FDG, and 18F-FDG PET-CT scan will be performed. After the 18F-FDG PET CT scans, the investigators will measure insulin sensitivity by performing an oral glucose tolerance test.
After this visit, subjects will start using bromocriptine (1,25mg/day during the first week and 2,50mg/day during the second week) in the evening.
Visit 3(2 weeks after visit 2) will be exactly the same as visit 2. In the three days before visit 2 and 3, subjects will record their eating behaviour.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 8 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
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Exclusion Criteria:
Subjects will be investigated before and after the use of bromocriptine. They will use bromocriptine for two weeks in the evening (1.25mg/day during the first week and 2.5mg/day during the second week).
Drug: Bromocriptine
The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself
Also known as: Parlodel
Difference in 18F-FDG uptake before and after using bromocriptin
BAT activity is assessed with a FDG-PET CT scan
Time frame: 17 months
Difference in energy expenditure before and after using bromocriptin
energy expenditure is a measure for BAT activity
Time frame: 17 months
Difference in core body temperature before and after using bromocriptin
Body temperature might be influenced by BAT activity
Time frame: 17 months
Difference in insulin sensitivity before and after using bromocriptin
Insulin sensitivity might be influenced by BAT activity
Time frame: 17 months
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bromocriptine
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) →