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CompletedNCT02786251BAT-TGUpdated Mar 15, 2022

The Role of Brown Adipose Tissue in Triglyceride Clearance in People

An interventional study of Cold exposure and Exposure to thermoneutral conditions in Obesity, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-15.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
Female
01

Study summary

The recent discovery of functional brown adipose tissue (BAT) in humans has led to a paradigm shift in adipose tissue biology; it is now believed that adipocytes may play a significant role in regulating substrate metabolism. Given that the resurgence in the interest in human BAT is still in its infancy, a number of fundamental questions pertaining to the role of BAT in human physiology remain unanswered. One area of particular importance, but poorly understood, is the potential effect of BAT on triglyceride (TG) metabolism. Data from a series of studies have found that BAT is inversely associated with adiposity, high blood lipids, and fatty liver in people. However, the role of BAT in the regulation of TG metabolism in people is not known. The overall goal of this study is to determine the physiological importance of the human BAT in TG metabolism. To this end, we are planning to study overweight/obese women with high amounts of BAT (BAT+, n=14) and with no/minimal BAT (BAT-, n=14) both under thermoneutrality and mild cold exposure (\~2 weeks apart). The investigators hypothesize that BAT+ participants will demonstrate greater plasma very low-density lipoprotein triglycerides (VLDL-TG) clearance rate compared to BAT- participants, and higher expression of genes involved in lipid metabolism only in BAT (but not muscle and white adipose tissue). Infusion of stable isotope tracers and metabolic modeling techniques will be used to assess VLDL-TG kinetics. Positron emission tomography computed tomography will be used for the identification and quantification of BAT. Supraclavicular BAT, abdominal white adipose tissue, and skeletal muscle tissue biopsies during cold exposure and thermoneutral conditions in conjunction with molecular biology techniques will used to measure expression of genes involved in lipid metabolism.

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Conditions studied

  • Obesity

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03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 29 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥21 and ≤65 years
  • BMI 25.0-35.0 kg/m²

Exclusion criteria

Exclusion Criteria:

  • Men
  • Previous bariatric surgery or gastrointestinal surgery
  • Structured exercise >2 days/week for ≥35 min of intense exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥150 min per week of moderate intensity exercise (e.g., brisk walking)
  • Unstable weight (>5% change during the last 2 months before entering the study)
  • Significant organ system dysfunction (e.g., diabetes requiring medications, severe pulmonary, disorders of the gastrointestinal tract, kidney or cardiovascular disease)
  • Current cancer or cancer that has been in remission for \<5 years
  • Conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
  • Use of medications that are judged by the investigators to affect the study outcome measures or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study
  • Smoke cigarettes or use of illegal drugs
  • Consumption of >14 units of alcohol (e.g., glass of wine or bottle of beer) per week
  • Pregnant or lactating
  • Persons who are not able to grant voluntary informed consent
  • Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Other
    BAT+

    Individuals with significant amounts of BAT (\>20 ml)

    Other: Cold exposure · Other: Exposure to thermoneutral conditions

  • Other
    BAT-

    Individuals with no/minimal amounts of BAT (\<20 ml)

    Other: Cold exposure · Other: Exposure to thermoneutral conditions

Interventions

  • OtherCold exposure

    During cold exposure intervention, we will use an individualized cold exposure protocol above the individual shivering threshold of each participant using liquid condition garments and a temperature controlled room.

  • OtherExposure to thermoneutral conditions

    For the thermoneutral conditions intervention, subjects will be exposed to thermoneutral conditions (\~26-28°C).

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What researchers measure

Primary outcomes

  1. Rate of VLDL-TG clearance

    The rate of VLDL-TG clearance from plasma will be assessed using infusion of stable isotopes.

    Time frame: 12 hours

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Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
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References and documents

Publications

  • Chondronikola M, Yoshino J, Ramaswamy R, Giardina JD, Laforest R, Wahl RL, Patterson BW, Mittendorfer B, Klein S. Very-low-density lipoprotein triglyceride and free fatty acid plasma kinetics in women with high or low brown adipose tissue volume and overweight/obesity. Cell Rep Med. 2024 Jan 16;5(1):101370. doi: 10.1016/j.xcrm.2023.101370. PubMed 38232692 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02786251
Responsible party
Sponsor
First posted
May 30, 2016
Start date
May 2016
Primary completion
Jun 2019
Completion
Jun 2019
Last update
Mar 15, 2022

Study contacts

Maria Chondronikola, PhD, RDN
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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