Circadian Brown Adipose Tissue Metabolism

NCT02285270 | Completed Results

• 1 other identifier: 819607
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Brown adipose tissue is poorly understood fat that can metabolize glucose in order to generate heat. Since activated brown fat has a high metabolic rate, it is of great interest as a potential target to combat obesity. However, the signaling and control of brown fat metabolism is poorly understood. Because brown fat uses glucose as its energy source, brown fat metabolism can be imaged with PET/CT using the positron emitting glucose analog F-18 FDG. We have recently shown in mice a striking circadian variation in brown fat metabolism as evidenced by changes in FDG uptake. In this study we endeavor to generate pilot data on a potential circadian variation in brown fat activation in healthy humans.

Conditions

Healthy

Keywords

Circadian rhythm; Adipose tissue, brown; Metabolism

Outcome Measures

Primary Outcomes (1)

• Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging

  ~12-hours

Secondary Outcomes (2)

• Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake

  ~12-hours

• Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean)

  ~12-hours

Study Arms (1)

Single group assignment

OTHER

Diagnostic test/procedure - FDG PET/CT

Device: FDG PET/CT

Interventions

FDG PET/CT DEVICE

PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan.

Single group assignment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least 18 years of age and less than 45 years of age
• Able and willing to provide informed consent
• Male gender
• Capable of complying with study procedures and able to lie still in the PET/CT scanner for up to 40 minutes continuously
• Normal fasting glucose (less than 100 mg/dl)
• No evidence of significant concurrent illness
• Follow typical sleep/wake cycle of generally asleep at night and awake during the day

You may not qualify if:

• Prior surgery or radiation to the head, neck, or upper chest (except surgeries such as tonsillectomy/adenoidectomy/tympanostomy that would not be expected, in the judgement of the investigator, to have disrupted the adipose tissue in the neck or the upper chest)
• Active addiction or illicit drug abuse
• BMI greater than 25
• Employment in the night shift/3rd shift
• Unable to remain in the Clinical and Translational Research Center (CTRC) for entire 24 hour period.
• Unable or unwilling to maintain peripheral intravenous access for up to 24 hours
• Abnormal liver or kidney function (serum creatinine or transaminase levels greater than 1.5 ULN)
• Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete, high quality data

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• The nuclear receptor Rev-erbα controls circadian thermogenic plasticity.

Results Point of Contact

• Title: Daniel Pryma
• Organization: University of Pennsylvania

daniel.pryma@uphs.upenn.edu

215-349-5272

Study Officials

• Daniel Pryma, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 7, 2016
• Results First Posted: June 17, 2016

Record last verified: 2016-10

Locations

US (1)