NCT02941172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

2.6 years

First QC Date

October 19, 2016

Last Update Submit

December 18, 2018

Conditions

Obesity

Keywords

Brown adipose tissueCannabinoid receptorPET imagingMetabolism

Outcome Measures

Primary Outcomes (1)

  • CB1 density of brown adipose tissue acquired with PET

    PET imaging is used to quantify CB1 receptors in tissues

    within one study day

Secondary Outcomes (1)

  • Glucose uptake of brown adipose tissue acquired with PET

    within one study day

Study Arms (3)

[18F]FMPEP-d2 in warm conditions

OTHER

PET scan is performed using PET radiotracer \[18F\]FMPEP-d2 in standard room temperature conditions.

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.

Other: Cold exposureOther: [18F]FMPEP-d2

[18F]FDG in cold conditions

OTHER

PET scan is performed using PET radiotracer \[18F\]FDG during controlled cold exposure.

Other: Cold exposureOther: [18F]FDG

Interventions

Cold exposureOTHER

Controlled cold exposure is performed before and during PET scan

[18F]FDG in cold conditions[18F]FMPEP-d2 in cold conditions
[18F]FMPEP-d2OTHER

PET radiotracer used in imaging

[18F]FMPEP-d2 in cold conditions[18F]FMPEP-d2 in warm conditions
[18F]FDGOTHER

PET radiotracer used in imaging

[18F]FDG in cold conditions

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre (Turku University Hospital)

Turku, 20521, Finland

Location

Related Publications (1)

  • 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.

    PMID: 29650773DERIVED

MeSH Terms

Conditions

Obesity

Interventions

5-((3-fluoromethoxy)phenyl)-3-(1-phenylethylamino)-1-(4-trifluoromethylphenyl)pyrrolidin-2-oneFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Pirjo Nuutila, M.D., Ph.D.

    Turku PET Centre (Turku University Hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 21, 2016

Study Start

January 1, 2015

Primary Completion

July 30, 2017

Study Completion

December 30, 2017

Last Updated

December 20, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)