N/A
N=10
Circadian Brown Adipose Tissue Metabolism
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02285270 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FDG PET/CT (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Pennsylvania
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
— | — |
| SECONDARY Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake |
— | — |
| SECONDARY Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02285270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.