DEBAT: Dopaminergic Effects on Brown Adipose Tissue

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Completed

CT.gov ID

NCT02428933

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Dopaminergic Effects on Brown Adipose Tissue: the DEBAT Trial

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	Drug: Bromocriptine The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself Other Names: Parlodel

Arm

Intervention/Treatment

Other: 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).

Drug: Bromocriptine

The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself

Other Names:

Parlodel

Outcome Measures

Primary Outcome Measures

Difference in 18F-FDG uptake before and after using bromocriptin [17 months]
BAT activity is assessed with a FDG-PET CT scan

Secondary Outcome Measures

Difference in energy expenditure before and after using bromocriptin [17 months]
energy expenditure is a measure for BAT activity
Difference in core body temperature before and after using bromocriptin [17 months]
Body temperature might be influenced by BAT activity
Difference in insulin sensitivity before and after using bromocriptin [17 months]
Insulin sensitivity might be influenced by BAT activity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male
Caucasian origin
Subjects should be able and willing to give informed consent
18-30 years old
BMI range of 19-25 kg/m2

Exclusion Criteria:

Renal failure (creatinine>135mmol/l)
Liver failure (AST/ (Alanine Aminotransferase) ALT > 3 times higher than the normal upper value)
Daily use of prescription medication
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 tumor (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 should not take this medicine.
Prior participation in a research protocol involving radiation exposure in the last 2 years