Dopaminergic Effects on Brown Adipose Tissue: the DEBAT trial

Dopaminergic Effects on Brown Adipose Tissue: the DEBAT trial - DEBAT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38797

Enrollment

Registered

2013-07-09

Start date

2013-10-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Overweight

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male Caucasian Origin 18-30 years old BMI range 19-25kg/m2 Subjects should be able and willing to give informed consent.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To investigate whether bromocriptine influences the metabolic activity of BAT, as assessed with a FDG-PET CT scan	—

Secondary

Measure	Time frame
1) To investigate whether peripheral factors affect the (supposed) central effect of bromocriptine on BAT activity as assessed with FDG-PET CT scan by combining bromocriptine with domperidone. 2) To determine whether the difference in resting energy expenditure during thermoneutral conditions correlates with the metabolic BAT activity as assessed with FDG in subjects using nothing compared to bromocriptine or bromocriptine compared to bromocriptine combined with domperidone. 3) To determine if the glucose tolerance (as assessed with HOMA-indexes) correlates with metabolic BAT activity as assessed with FDG in subjects using nothing compared to using bromocriptine. 4) To determine if the sympathetic tonus (as assessed with continues blood pressure measuring using the fina press) differs when using bromocriptine or bromocriptine combined with domperidone as compared to nothing.	—

Measure

Time frame

1) To investigate whether peripheral factors affect the (supposed) central effect of bromocriptine on BAT activity as assessed with FDG-PET CT scan by combining bromocriptine with domperidone. 2) To determine whether the difference in resting energy expenditure during thermoneutral conditions correlates with the metabolic BAT activity as assessed with FDG in subjects using nothing compared to bromocriptine or bromocriptine compared to bromocriptine combined with domperidone. 3) To determine if the glucose tolerance (as assessed with HOMA-indexes) correlates with metabolic BAT activity as assessed with FDG in subjects using nothing compared to using bromocriptine. 4) To determine if the sympathetic tonus (as assessed with continues blood pressure measuring using the fina press) differs when using bromocriptine or bromocriptine combined with domperidone as compared to nothing.

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Countries

Netherlands

Outcome results