Adenosine and A2A Receptors in Human Brown Adipose Tissue

NCT03327168 | Completed

• 1 other identifier: T201/2015
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates the significance of adenosine and A2A receptors in human brown adipose tissue (BAT) in vivo. Using positron emission tomography (PET), perfusion and the density of A2A receptors will be measured in supraclavicular BAT and other tissues in healthy men. The investigators hypothesize, that adenosine can activate BAT, and that adenosine A2A receptor density changes when BAT is activated by cold exposure. 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.

Conditions

Obesity

Keywords

Adipose Tissue, Brown

Outcome Measures

Primary Outcomes (2)

• BAT perfusion

  Perfusion of BAT with \[15O\]-H2O PET-CT

  Effect within 10 minutes

• A2A receptor density in BAT

  Density of A2A receptors in BAT measured with \[11C\]-TMSX PET/CT

  Effect within 3 hours

Study Arms (3)

Adenosine

ACTIVE COMPARATOR

Perfusion is measured using PET/CT during intravenous infusion (0.14 mg/kg/min) of adenosine.

Drug: Adenosine

Room temperature

NO INTERVENTION

Perfusion and A2A receptor density is measured using PET/CT in resting room temperature conditions.

Cold exposure

EXPERIMENTAL

Perfusion and A2A receptor density is measured using PET/CT during controlled cold exposure.

Other: Cold exposure

Interventions

Adenosine DRUG

Intravenous infusion of adenosine (0.14 mg/kg) is administered for 5 minutes during PET/CT scan.

Also known as: Adenocor

Adenosine

Cold exposure OTHER

Controlled cold exposure is performed before and during PET/CT scan.

Cold exposure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male sex
• BMI 20 - 28 kg/m2
• Age: 18- 40 years
• Normal OGTT
• Healthy, no regular medication

You may not qualify if:

• BMI \< 20 kg/m2 or BMI \> 28 kg/m2
• Low or high blood pressure
• Asthma or other obstructive lung disease
• Sick sinus syndrome, prolonged QT-interval, or any heart disease
• Any chronic disease that could affect the study outcome, including diabetes
• Mental disorder or poor compliance
• Eating disorder or excessive use of alcohol, tobacco smoking or drug use
• Past dose of radiation
• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Bonn: collaborator

MeSH Terms

Conditions

Obesity

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Kirsi A Virtanen, MD, PhD

  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: Adjunct Professor

Model Details: Each subject participates in PET/CT scans in room temperature conditions, during cold exposure and during i.v. infusion of adenosine.

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 31, 2017
• Study Start: November 1, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share