Dopaminergic Effects on Brown Adipose Tissue: the DEBAT trial
- Conditions
- ObesityOverweight1001842410024450
- Registration Number
- NL-OMON38797
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Male Caucasian Origin 18-30 years old BMI range 19-25kg/m2 Subjects should be able and willing to give informed consent.
Renal failure (creatinine >135 mmol/L), liverfailure (AST/ALT > 3 times higher than the normal upper value), Daily use of prescription medicine or drug use, Prior participation in a research protocol involving radiation exposure in the last 2 years, Known hypersensitivity to bromocriptine, domperidone maleate or other ergot alkaloids. Uncontrolled hypertension. Known history of coronary artery disease, or other severe cardiovascular conditions (such as a prolonged Qtc-time), or symptoms / history of severe psychiatric disorders. Known cardiac valvulopathy
Prolactin-releasing pituitary tumour (prolactinoma).Cases where stimulation of the gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation.
Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate whether bromocriptine influences the metabolic activity of BAT,<br /><br>as assessed with a FDG-PET CT scan </p><br>
- Secondary Outcome Measures
Name Time Method <p>1) To investigate whether peripheral factors affect the (supposed) central<br /><br>effect of bromocriptine on BAT activity as assessed with FDG-PET CT scan by<br /><br>combining bromocriptine with domperidone.<br /><br>2) To determine whether the difference in resting energy expenditure during<br /><br>thermoneutral conditions correlates with the metabolic BAT activity as assessed<br /><br>with FDG in subjects using nothing compared to bromocriptine or bromocriptine<br /><br>compared to bromocriptine combined with domperidone.<br /><br>3) To determine if the glucose tolerance (as assessed with HOMA-indexes)<br /><br>correlates with metabolic BAT activity as assessed with FDG in subjects using<br /><br>nothing compared to using bromocriptine.<br /><br>4) To determine if the sympathetic tonus (as assessed with continues blood<br /><br>pressure measuring using the fina press) differs when using bromocriptine or<br /><br>bromocriptine combined with domperidone as compared to nothing.</p><br>