Dopaminergic Effects on Brown Adipose Tissue (DEBAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02428933|
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : April 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: Bromocriptine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dopaminergic Effects on Brown Adipose Tissue: the DEBAT Trial|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Before and after bromocriptine
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).
The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself
Other Name: Parlodel
- Difference in 18F-FDG uptake before and after using bromocriptin [ Time Frame: 17 months ]BAT activity is assessed with a FDG-PET CT scan
- Difference in energy expenditure before and after using bromocriptin [ Time Frame: 17 months ]energy expenditure is a measure for BAT activity
- Difference in core body temperature before and after using bromocriptin [ Time Frame: 17 months ]Body temperature might be influenced by BAT activity
- Difference in insulin sensitivity before and after using bromocriptin [ Time Frame: 17 months ]Insulin sensitivity might be influenced by BAT activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428933
|Academic Medical Center|
|Principal Investigator:||Frits Holleman, Dr. MD.||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|