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The Role of Brown Adipose Tissue in Triglyceride Clearance in People (BAT-TG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786251
Recruitment Status : Active, not recruiting
First Posted : May 30, 2016
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Other: Cold exposure Other: Exposure to thermoneutral conditions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Role of Brown Adipose Tissue in Triglyceride Clearance in People
Actual Study Start Date : May 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
BAT+
Individuals with significant amounts of BAT (>20 ml)
Other: Cold 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.

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

BAT-
Individuals with no/minimal amounts of BAT (<20 ml)
Other: Cold 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.

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




Primary Outcome Measures :
  1. Rate of VLDL-TG clearance [ Time Frame: 12 hours ]
    The rate of VLDL-TG clearance from plasma will be assessed using infusion of stable isotopes.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786251


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Maria Chondronikola, PhD, RDN University of California, Davis
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02786251    
Other Study ID Numbers: 201602059
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No