CB1 Receptors in Human Brown Adipose Tissue (CANBAT)

• ClinicalTrials.gov Identifier: NCT02941172
• Recruitment Status: Completed
• First Posted: October 21, 2016
• Last Update Posted: December 20, 2018
• Sponsor: Turku University Hospital
• Information provided by (Responsible Party): Pirjo Nuutila, Turku University Hospital

Tracking Information

• First Submitted Date: October 19, 2016
• First Posted Date: October 21, 2016
• Last Update Posted Date: December 20, 2018
• Study Start Date: January 2015
• Actual Primary Completion Date: July 30, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2016)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 19, 2016)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CB1 Receptors in Human Brown Adipose Tissue
• Official Title: Cannabinoid CB1 Receptors in Human Brown Adipose Tissue

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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Obesity

Intervention

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

Study Arms

• [18F]FMPEP-d2 in warm conditions
  PET scan is performed using PET radiotracer [18F]FMPEP-d2 in standard room temperature conditions.
  Intervention: Other: [18F]FMPEP-d2
• [18F]FMPEP-d2 in cold conditions
  PET scan is performed using PET radiotracer [18F]FMPEP-d2 during controlled cold exposure.
  Interventions:

  • Other: Cold exposure
  • Other: [18F]FMPEP-d2
• [18F]FDG in cold conditions
  PET scan is performed using PET radiotracer [18F]FDG during controlled cold exposure.
  Interventions:

  • Other: Cold exposure
  • Other: [18F]FDG

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 18, 2018): 18
• Original Estimated Enrollment (submitted: October 19, 2016): 20
• Actual Study Completion Date: December 30, 2017
• Actual Primary Completion Date: July 30, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT02941172
• Other Study ID Numbers: 42/2014
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pirjo Nuutila, Turku University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Turku University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pirjo Nuutila, M.D., Ph.D.; Turku PET Centre (Turku University Hospital)

• PRS Account: Turku University Hospital
• Verification Date: December 2018