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CB1 Receptors in Human Brown Adipose Tissue (CANBAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02941172
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pirjo Nuutila, Turku University Hospital

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
Obesity Other: Cold exposure Other: [18F]FMPEP-d2 Other: [18F]FDG Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cannabinoid CB1 Receptors in Human Brown Adipose Tissue
Study Start Date : January 2015
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : December 30, 2017
Arms and Interventions
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Arm Intervention/treatment
[18F]FMPEP-d2 in warm conditions
PET scan is performed using PET radiotracer [18F]FMPEP-d2 in standard room temperature conditions.
 Other: [18F]FMPEP-d2
PET radiotracer used in imaging
[18F]FMPEP-d2 in cold conditions
PET scan is performed using PET radiotracer [18F]FMPEP-d2 during controlled cold exposure.
 Other: Cold exposure
Controlled cold exposure is performed before and during PET scan

Other: [18F]FMPEP-d2
PET radiotracer used in imaging
[18F]FDG in cold conditions
PET scan is performed using PET radiotracer [18F]FDG during controlled cold exposure.
 Other: Cold exposure
Controlled cold exposure is performed before and during PET scan

Other: [18F]FDG
PET radiotracer used in imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Glucose uptake of brown adipose tissue acquired with PET [ Time Frame: within one study day ]
    PET imaging is used to quantify glucose uptake in tissues


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer
  • Group 1: BMI 20-26 kg/m2, Group2: BMI 27-40 kg/m2

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941172


Locations
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Finland
Turku PET Centre (Turku University Hospital)
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Pirjo Nuutila, M.D., Ph.D. Turku PET Centre (Turku University Hospital)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pirjo Nuutila, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02941172    
Other Study ID Numbers: 42/2014
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pirjo Nuutila, Turku University Hospital:
Brown adipose tissue
Cannabinoid receptor
PET imaging
Metabolism