ObesityAdenoBATNCT03327168
Adenosine and A2A Receptors in Human Brown Adipose Tissue
A study testing Adenosine and Cold exposure in people with Obesity, run by Turku University Hospital.
Trial summary
This study investigates the significance of adenosine and A2A receptors in human brown adipose tissue (BAT) in vivo. Using positron emission tomography (PET), perfusion and the density of A2A receptors will be measured in supraclavicular BAT and other tissues in healthy men. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Adenosine and Cold exposure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 30 Jun 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- BMI 20 - 28 kg/m2
- Age: 18- 40 years
- Normal OGTT
- Healthy, no regular medication
Who cannot join
- BMI < 20 kg/m2 or BMI > 28 kg/m2
- Low or high blood pressure
- Asthma or other obstructive lung disease
- Sick sinus syndrome, prolonged QT-interval, or any heart disease
- Any chronic disease that could affect the study outcome, including diabetes
- Mental disorder or poor compliance
Show all 9Show fewer
- Eating disorder or excessive use of alcohol, tobacco smoking or drug use
- Past dose of radiation
- Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
About this study
Official title: Adenosine and A2a Receptors in Human Brown Adipose Tissue (AdenoBAT)
This study investigates the significance of adenosine and A2A receptors in human brown adipose tissue (BAT) in vivo. Using positron emission tomography (PET), perfusion and the density of A2A receptors will be measured in supraclavicular BAT and other tissues in healthy men. The investigators hypothesize, that adenosine can activate BAT, and that adenosine A2A receptor density changes when BAT is activated by cold exposure.
Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is important and beneficial in fighting against the epidemic of obesity and diabetes.
Read the detailed description
Adenosine is a purine nucleoside released locally in BAT when noradrenaline and ATP are released from sympathetic nerves. Recently it was found that adenosine activates murine and human brown adipocytes, and recruits beiging of white fat via adenosine A2A receptors (A2AR). Furthermore, studies with mice have shown improvements in glucose homeostasis after administration of A2AR agonists.
In this study the investigators use the PET radiotracer [15O]-H2O to quantify perfusion of BAT, white adipose tissue (WAT) and muscle in three conditions: room temperature, cold exposure and intravenous infusion of adenosine. Another PET radiotracer [11C]TMSX is used to quantify adenosine A2A receptor density of BAT, WAT and muscle in room temperature and during cold exposure.
- Conditions
- Obesity
- Being tested
- Adenosine, Cold exposure
- Keywords
- Adipose Tissue, Brown
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Also called Adenocor
Intravenous infusion of adenosine (0.14 mg/kg) is administered for 5 minutes during PET/CT scan.
Cold exposureOther
Controlled cold exposure is performed before and during PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| Adenosine | Active comparator | Perfusion is measured using PET/CT during intravenous infusion (0.14 mg/kg/min) of adenosine. Receives: Drug: Adenosine |
| Room temperature | No intervention | Perfusion and A2A receptor density is measured using PET/CT in resting room temperature conditions. |
| Cold exposure | Experimental | Perfusion and A2A receptor density is measured using PET/CT during controlled cold exposure. Receives: Other: Cold exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAT perfusion
Perfusion of BAT with [15O]-H2O PET-CT
Measured: Effect within 10 minutes
A2A receptor density in BAT
Density of A2A receptors in BAT measured with [11C]-TMSX PET/CT
Measured: Effect within 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Nov 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
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.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each subject participates in PET/CT scans in room temperature conditions, during cold exposure and during i.v. infusion of adenosine.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Bonn
- Responsible party
- Principal investigator, Kirsi Virtanen, Turku University Hospital
- Investigators
- Kirsi A Virtanen, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327168
- Sponsor's protocol ID
- T201/2015
- Acronym
- AdenoBAT
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine and A2a Receptors in Human Brown Adipose Tissue (AdenoBAT)
- ClinicalTrials.gov ID
- NCT03327168
- Acronym / sponsor ID
- AdenoBAT / T201/2015
- Conditions
- Obesity
- Keywords
- Adipose Tissue, Brown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Bonn
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 31 Oct 2017 (actual)
- 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.
This study investigates the significance of adenosine and A2A receptors in human brown adipose tissue (BAT) in vivo. Using positron emission tomography (PET), perfusion and the density of A2A receptors will be measured in supraclavicular BAT and other tissues in healthy men. The investigators hypothesize, that adenosine can activate BAT, and that adenosine A2A receptor density changes when BAT is activated by cold exposure.
Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is important and beneficial in fighting against the epidemic of obesity and diabetes.
Detailed description
Adenosine is a purine nucleoside released locally in BAT when noradrenaline and ATP are released from sympathetic nerves. Recently it was found that adenosine activates murine and human brown adipocytes, and recruits beiging of white fat via adenosine A2A receptors (A2AR). Furthermore, studies with mice have shown improvements in glucose homeostasis after administration of A2AR agonists.
In this study the investigators use the PET radiotracer [15O]-H2O to quantify perfusion of BAT, white adipose tissue (WAT) and muscle in three conditions: room temperature, cold exposure and intravenous infusion of adenosine. Another PET radiotracer [11C]TMSX is used to quantify adenosine A2A receptor density of BAT, WAT and muscle in room temperature and during cold exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each subject participates in PET/CT scans in room temperature conditions, during cold exposure and during i.v. infusion of adenosine.
| Arm | Type | Receives |
|---|---|---|
| Adenosine | Active comparator | Drug: AdenosinePerfusion is measured using PET/CT during intravenous infusion (0.14 mg/kg/min) of adenosine. |
| Room temperature | No intervention | –Perfusion and A2A receptor density is measured using PET/CT in resting room temperature conditions. |
| Cold exposure | Experimental | Other: Cold exposurePerfusion and A2A receptor density is measured using PET/CT during controlled cold exposure. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male sex
- BMI 20 - 28 kg/m2
- Age: 18- 40 years
- Normal OGTT
- Healthy, no regular medication
Key exclusion criteria (9 listed)
- BMI < 20 kg/m2 or BMI > 28 kg/m2
- Low or high blood pressure
- Asthma or other obstructive lung disease
- Sick sinus syndrome, prolonged QT-interval, or any heart disease
- Any chronic disease that could affect the study outcome, including diabetes
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 |
|---|---|---|
| AdenosineAlso: AdenocorIntravenous infusion of adenosine (0.14 mg/kg) is administered for 5 minutes during PET/CT scan. | Drug | Adenosine |
| Cold exposureControlled cold exposure is performed before and during PET/CT scan. | Other | Cold exposure |
Primary outcome
BAT perfusion
Time frame: Effect within 10 minutes
Perfusion of BAT with [15O]-H2O PET-CT
A2A receptor density in BAT
Time frame: Effect within 3 hours
Density of A2A receptors in BAT measured with [11C]-TMSX PET/CT
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 6 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Kirsi A Virtanen, MD, PhD principal investigator
Turku University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine and Cold exposure in people with Obesity, run by Turku University Hospital.
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 9 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
BAT perfusion (time frame: Effect within 10 minutes). The study lists 2 primary outcomes in all. 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 6 Nov 2017.