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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)

Tracking Information
First Submitted Date  ICMJE October 17, 2014
First Posted Date  ICMJE April 29, 2015
Last Update Posted Date April 29, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
Difference in 18F-FDG uptake before and after using bromocriptin [ Time Frame: 17 months ]
BAT activity is assessed with a FDG-PET CT scan
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
  • Difference in energy expenditure before and after using bromocriptin [ Time Frame: 17 months ]
    energy expenditure is a measure for BAT activity
  • Difference in core body temperature before and after using bromocriptin [ Time Frame: 17 months ]
    Body temperature might be influenced by BAT activity
  • Difference in insulin sensitivity before and after using bromocriptin [ Time Frame: 17 months ]
    Insulin sensitivity might be influenced by BAT activity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dopaminergic Effects on Brown Adipose Tissue
Official Title  ICMJE Dopaminergic Effects on Brown Adipose Tissue: the DEBAT Trial
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Obesity
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Drug: Bromocriptine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2015)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02428933
Other Study ID Numbers  ICMJE METC nr 2013_107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frits Holleman, Dr. MD. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP