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Dopaminergic Effects on Brown Adipose Tissue (DEBAT)

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ClinicalTrials.gov Identifier: NCT02428933
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 Not Applicable

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.


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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Parlodel




Primary Outcome Measures :
  1. Difference in 18F-FDG uptake before and after using bromocriptin [ Time Frame: 17 months ]
    BAT activity is assessed with a FDG-PET CT scan


Secondary Outcome Measures :
  1. Difference in energy expenditure before and after using bromocriptin [ Time Frame: 17 months ]
    energy expenditure is a measure for BAT activity

  2. Difference in core body temperature before and after using bromocriptin [ Time Frame: 17 months ]
    Body temperature might be influenced by BAT activity

  3. Difference in insulin sensitivity before and after using bromocriptin [ Time Frame: 17 months ]
    Insulin sensitivity might be influenced by BAT activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Frits Holleman, Dr. MD. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: F Holleman, Dr. MD., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02428933     History of Changes
Other Study ID Numbers: METC nr 2013_107
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Brown Adipose Tissue
Obesity
Insulin Sensitivity
Dopamine

Additional relevant MeSH terms:
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Dopamine
Bromocriptine
Dopamine Agents
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists