Dopaminergic Effects on Brown Adipose Tissue

Obesity Clinical Trial

— DEBAT  

Official title:

Dopaminergic Effects on Brown Adipose Tissue: the DEBAT Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428933
• Other study ID #: METC nr 2013_107
• Status: Completed
• Phase: N/A
• First received: October 17, 2014
• Last updated: April 24, 2015
• Start date: October 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in 18F-FDG uptake before and after using bromocriptin	BAT activity is assessed with a FDG-PET CT scan	17 months	No
Secondary	Difference in energy expenditure before and after using bromocriptin	energy expenditure is a measure for BAT activity	17 months	No
Secondary	Difference in core body temperature before and after using bromocriptin	Body temperature might be influenced by BAT activity	17 months	No
Secondary	Difference in insulin sensitivity before and after using bromocriptin	Insulin sensitivity might be influenced by BAT activity	17 months	No