CB1 Receptors in Human Brown Adipose Tissue

NCT ID: NCT02941172

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-30

Brief Summary

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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

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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

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Obesity

Keywords

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Brown adipose tissue Cannabinoid receptor PET imaging Metabolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[18F]FMPEP-d2 in warm conditions

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

Group Type OTHER

[18F]FMPEP-d2

Intervention Type OTHER

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.

Group Type OTHER

Cold exposure

Intervention Type OTHER

Controlled cold exposure is performed before and during PET scan

[18F]FMPEP-d2

Intervention Type OTHER

PET radiotracer used in imaging

[18F]FDG in cold conditions

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

Group Type OTHER

Cold exposure

Intervention Type OTHER

Controlled cold exposure is performed before and during PET scan

[18F]FDG

Intervention Type OTHER

PET radiotracer used in imaging

Interventions

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Cold exposure

Controlled cold exposure is performed before and during PET scan

Intervention Type OTHER

[18F]FMPEP-d2

PET radiotracer used in imaging

Intervention Type OTHER

[18F]FDG

PET radiotracer used in imaging

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Pirjo Nuutila

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pirjo Nuutila, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Turku PET Centre (Turku University Hospital)

Locations

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Turku PET Centre (Turku University Hospital)

Turku, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 29650773 (View on PubMed)

Other Identifiers

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42/2014

Identifier Type: -

Identifier Source: org_study_id