- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02428933
Dopaminergic Effects on Brown Adipose Tissue (DEBAT)
Dopaminergic Effects on Brown Adipose Tissue: the DEBAT Trial
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.
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Amsterdam, Netherlands
- Academic Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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).
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The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in 18F-FDG uptake before and after using bromocriptin
Time Frame: 17 months
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BAT activity is assessed with a FDG-PET CT scan
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17 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in energy expenditure before and after using bromocriptin
Time Frame: 17 months
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energy expenditure is a measure for BAT activity
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17 months
|
Difference in core body temperature before and after using bromocriptin
Time Frame: 17 months
|
Body temperature might be influenced by BAT activity
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17 months
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Difference in insulin sensitivity before and after using bromocriptin
Time Frame: 17 months
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Insulin sensitivity might be influenced by BAT activity
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17 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frits Holleman, Dr. MD., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dopamine Agonists
- Dopamine Agents
- Hormone Antagonists
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Bromocriptine
Other Study ID Numbers
- METC nr 2013_107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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