ObesityCANBATNCT02941172
CB1 Receptors in Human Brown Adipose Tissue
A study testing Cold exposure, [18F]FMPEP-d2 and [18F]FDG in people with Obesity, run by Turku University Hospital at 1 site in Finland.
Trial summary
This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in room temperature conditions and during controlled cold exposure, and the density of CB1 receptors in BAT and other tissues will be… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Cold exposure, [18F]FMPEP-d2 and [18F]FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2015to 30 Dec 2017
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- Group 1: BMI 20-26 kg/m2, Group2: BMI 27-40 kg/m2
Who cannot join
- BMI < 20 kg/m2or BMI > 40 kg/m2
- Any chronic disease that could affect the study outcome, including medicated type 2 diabetes
- Mental disorder or poor compliance
- Eating disorder or excessive use of alcohol, tobacco smoking or drug use
- Past dose of radiation
- Presence of any ferromagnetic objects that would make MR imaging contraindicated
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cannabinoid CB1 Receptors in Human Brown Adipose Tissue
This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in room temperature conditions and during controlled cold exposure, and the density of CB1 receptors in BAT and other tissues will be quantified. The investigators hypothesize, that cannabinoid signaling is increased in cold conditions, when BAT is metabolically active.
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
Endocannabinoids have an important role in regulating energy balance and metabolism. Cannabinoid 1 receptors (CB1) are found in several tissues such as brown adipose tissue (BAT). Endocannabinoids and CB1 receptors participate in the control of lipid and glucose metabolism, and blockage of CB1 receptors has been found to improve metabolic factors linked to obesity and cardiovascular disease, making CB1 antagonists potential drugs against obesity and diabetes.
In this study the investigators use a PET radiotracer [18F]FMPEP-d2, which binds to CB1 receptors in vivo, to quantify the CB1 receptor density in BAT, white adipose tissue, muscle and the brain. This study is done once in warm conditions and once during controlled cold exposure. To verify whether the subject has metabolically active BAT, an additional PET scan with the radiotracer [18F]FDG is performed.
- Conditions
- Obesity
- Being tested
- Cold exposure, [18F]FMPEP-d2, [18F]FDG
- Keywords
- Brown adipose tissue, Cannabinoid receptor, PET imaging, Metabolism
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold exposureOther
Controlled cold exposure is performed before and during PET scan
[18F]FMPEP-d2Other
PET radiotracer used in imaging
[18F]FDGOther
PET radiotracer used in imaging
| Study group | Role | What they receive |
|---|---|---|
| [18F]FMPEP-d2 in warm conditions | Other | PET scan is performed using PET radiotracer [18F]FMPEP-d2 in standard room temperature conditions. Receives: Other: [18F]FMPEP-d2 |
| [18F]FMPEP-d2 in cold conditions | Other | PET scan is performed using PET radiotracer [18F]FMPEP-d2 during controlled cold exposure. Receives: Other: Cold exposure; Other: [18F]FMPEP-d2 |
| [18F]FDG in cold conditions | Other | PET scan is performed using PET radiotracer [18F]FDG during controlled cold exposure. Receives: Other: Cold exposure; Other: [18F]FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
CB1 density of brown adipose tissue acquired with PET
PET imaging is used to quantify CB1 receptors in tissues
Measured: within one study day
Secondary outcomes (1)
Glucose uptake of brown adipose tissue acquired with PET
PET imaging is used to quantify glucose uptake in tissues
Measured: within one study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startJan 2015
- Primary completion30 Jul 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pirjo Nuutila, Turku University Hospital
- Investigators
- Pirjo Nuutila, M.D., Ph.D., Principal investigator, Turku PET Centre (Turku University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941172
- Sponsor's protocol ID
- 42/2014
- Acronym
- CANBAT
- Status last verified
- Dec 2018
- First submitted
- 19 Oct 2016
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lahesmaa M, Eriksson O, Gnad T, Oikonen V, Bucci M, Hirvonen J, Koskensalo K, Teuho J, Niemi T, Taittonen M, Lahdenpohja S, U Din M, Haaparanta-Solin M, Pfeifer A, Virtanen KA, Nuutila P. Cannabinoid Type 1 Receptors Are Upregulated During Acute Activation of Brown Adipose Tissue. Diabetes. 2018 Jul;67(7):1226-1236. doi: 10.2337/db17-1366. Epub 2018 Apr 12.
PubMed 29650773
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoid CB1 Receptors in Human Brown Adipose Tissue
- ClinicalTrials.gov ID
- NCT02941172
- Acronym / sponsor ID
- CANBAT / 42/2014
- Conditions
- Obesity
- Keywords
- Brown adipose tissue, Cannabinoid receptor, PET imaging, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Jan 2015
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 21 Oct 2016 (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.
This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in room temperature conditions and during controlled cold exposure, and the density of CB1 receptors in BAT and other tissues will be quantified. The investigators hypothesize, that cannabinoid signaling is increased in cold conditions, when BAT is metabolically active.
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
Endocannabinoids have an important role in regulating energy balance and metabolism. Cannabinoid 1 receptors (CB1) are found in several tissues such as brown adipose tissue (BAT). Endocannabinoids and CB1 receptors participate in the control of lipid and glucose metabolism, and blockage of CB1 receptors has been found to improve metabolic factors linked to obesity and cardiovascular disease, making CB1 antagonists potential drugs against obesity and diabetes.
In this study the investigators use a PET radiotracer [18F]FMPEP-d2, which binds to CB1 receptors in vivo, to quantify the CB1 receptor density in BAT, white adipose tissue, muscle and the brain. This study is done once in warm conditions and once during controlled cold exposure. To verify whether the subject has metabolically active BAT, an additional PET scan with the radiotracer [18F]FDG is performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| [18F]FMPEP-d2 in warm conditions | Other | Other: [18F]FMPEP-d2PET scan is performed using PET radiotracer [18F]FMPEP-d2 in standard room temperature conditions. |
| [18F]FMPEP-d2 in cold conditions | Other | Other: Cold exposure, Other: [18F]FMPEP-d2PET scan is performed using PET radiotracer [18F]FMPEP-d2 during controlled cold exposure. |
| [18F]FDG in cold conditions | Other | Other: Cold exposure, Other: [18F]FDGPET scan is performed using PET radiotracer [18F]FDG during controlled cold exposure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteer
- Group 1: BMI 20-26 kg/m2, Group2: BMI 27-40 kg/m2
Key exclusion criteria (7 listed)
- BMI < 20 kg/m2or BMI > 40 kg/m2
- Any chronic disease that could affect the study outcome, including medicated type 2 diabetes
- Mental disorder or poor compliance
- Eating disorder or excessive use of alcohol, tobacco smoking or drug use
- Past dose of radiation
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 |
|---|---|---|
| Cold exposureControlled cold exposure is performed before and during PET scan | Other | [18F]FDG in cold conditions, [18F]FMPEP-d2 in cold conditions |
| [18F]FMPEP-d2PET radiotracer used in imaging | Other | [18F]FMPEP-d2 in cold conditions, [18F]FMPEP-d2 in warm conditions |
| [18F]FDGPET radiotracer used in imaging | Other | [18F]FDG in cold conditions |
Primary outcome
CB1 density of brown adipose tissue acquired with PET
Time frame: within one study day
PET imaging is used to quantify CB1 receptors in tissues
1 secondary outcome
Glucose uptake of brown adipose tissue acquired with PET
Time frame: within one study day
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 20 Dec 2018.
- Derived from this study: PubMed 29650773Lahesmaa M, Eriksson O, Gnad T, Oikonen V, Bucci M, Hirvonen J, Koskensalo K, Teuho J, Niemi T, Taittonen M, Lahdenpohja S, U Din M, Haaparanta-Solin M, Pfeifer A, Virtanen KA, Nuutila P. Cannabinoid Type 1 Receptors Are Upregulated During Acute Activation of Brown Adipose Tissue. Diabetes. 2018 Jul;67(7):1226-1236. doi: 10.2337/db17-1366. Epub 2018 Apr 12.
- 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.
Pirjo Nuutila, M.D., Ph.D. principal investigator
Turku PET Centre (Turku University Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold exposure, [18F]FMPEP-d2 and [18F]FDG in people with Obesity, run by Turku University Hospital at 1 site in Finland.
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 2 inclusion and 7 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 20 Dec 2018. 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 Finland. 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?
CB1 density of brown adipose tissue acquired with PET (time frame: within one study day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941172, which also lists 1 linked publication.
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 20 Dec 2018.