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CB1 Receptors in Human Brown Adipose Tissue (CANBAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pirjo Nuutila, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT02941172
First received: October 19, 2016
Last updated: October 31, 2016
Last verified: October 2016
  Purpose

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 Intervention
Obesity Other: Cold exposure Other: [18F]FMPEP-d2 Other: [18F]FDG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Cannabinoid CB1 Receptors in Human Brown Adipose Tissue

Further study details as provided by Pirjo Nuutila, Turku University Hospital:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 20
Study Start Date: January 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
[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

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02941172

Locations
Finland
Turku PET Centre (Turku University Hospital)
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Pirjo Nuutila, M.D., Ph.D. Turku PET Centre (Turku University Hospital)
  More Information

Responsible Party: Pirjo Nuutila, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02941172     History of Changes
Other Study ID Numbers: 42/2014
Study First Received: October 19, 2016
Last Updated: October 31, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Pirjo Nuutila, Turku University Hospital:
Brown adipose tissue
Cannabinoid receptor
PET imaging
Metabolism

ClinicalTrials.gov processed this record on June 23, 2017