ObesityDEBATNCT02428933
Dopaminergic Effects on Brown Adipose Tissue
A study testing Bromocriptine in people with Obesity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Bromocriptine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Caucasian origin
- Subjects should be able and willing to give informed consent
- 18-30 years old
- BMI range of 19-25 kg/m2
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Bromocriptine
- Keywords
- Brown Adipose Tissue, Obesity, Insulin Sensitivity, Dopamine
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromocriptineDrug
Also called Parlodel
The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself
| Study group | Role | What they receive |
|---|---|---|
| Before and after bromocriptine | Other | 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). Receives: Drug: Bromocriptine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in 18F-FDG uptake before and after using bromocriptin
BAT activity is assessed with a FDG-PET CT scan
Measured: 17 months
Secondary outcomes (3)
Difference in energy expenditure before and after using bromocriptin
energy expenditure is a measure for BAT activity
Measured: 17 months
Difference in core body temperature before and after using bromocriptin
Body temperature might be influenced by BAT activity
Measured: 17 months
Difference in insulin sensitivity before and after using bromocriptin
Insulin sensitivity might be influenced by BAT activity
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frits Holleman, Dr. MD., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428933
- Sponsor's protocol ID
- METC nr 2013_107
- Acronym
- DEBAT
- Status last verified
- Apr 2015
- First submitted
- 17 Oct 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Effects on Brown Adipose Tissue: the DEBAT Trial
- ClinicalTrials.gov ID
- NCT02428933
- Acronym / sponsor ID
- DEBAT / METC nr 2013_107
- Conditions
- Obesity
- Keywords
- Brown Adipose Tissue, Obesity, Insulin Sensitivity, Dopamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before and after bromocriptine | Other | Drug: BromocriptineSubjects 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). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Caucasian origin
- Subjects should be able and willing to give informed consent
- 18-30 years old
- BMI range of 19-25 kg/m2
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BromocriptineAlso: ParlodelThe investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself | Drug | Before and after bromocriptine |
Primary outcome
Difference in 18F-FDG uptake before and after using bromocriptin
Time frame: 17 months
BAT activity is assessed with a FDG-PET CT scan
3 secondary outcomes
Difference in energy expenditure before and after using bromocriptin
Time frame: 17 months
Difference in core body temperature before and after using bromocriptin
Time frame: 17 months
Difference in insulin sensitivity before and after using bromocriptin
Time frame: 17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frits Holleman, Dr. MD. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bromocriptine in people with Obesity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in 18F-FDG uptake before and after using bromocriptin (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.