Brown Adipose Tissue Pilot

NCT03793127 | Active Not Recruiting

• 1 other identifier: TRIMD 1344107
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this protocol is to develop a reliable method to determine BAT mass in young and older adults by magnetic resonance imaging.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Collection of imaging of BAT by magnetic resonance imaging from 10 participants in each of young and old study groups.

  Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2\* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method. The participant may be removed from the magnet and repositioned during the exam in order to determine the same day variability of this method.

  30 minutes

Study Arms (2)

Young group

20-40 years of age

Other: Maximal oxygen consumption (V02 max); Other: Brown adipose tissue (BAT) imaging; Other: Muscle function testing

Old group

60-80 years of age

Other: Maximal oxygen consumption (V02 max); Other: Brown adipose tissue (BAT) imaging; Other: Muscle function testing

Interventions

Maximal oxygen consumption (V02 max) OTHER

Aerobic fitness will be determined by measuring V02 max during a stationary bicycle exercise test.

Old group; Young group

Brown adipose tissue (BAT) imaging OTHER

Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2\* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method.

Old group; Young group

Muscle function testing OTHER

This test will be done on a machine called a Biodex. We will measure the speed at which subjects move resistance at different percentages of their peak strength.

Old group; Young group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females in the age ranges 20-40 and 60-80 years were recruited. Potential participants were medically screened to determine good health, weight stable (no gain/loss of ≥ 10 lbs in 6 months prior to screening), and without any contraindication to exercise. Approximately equal numbers of men and women will be recruited. Neither race nor ethnicity were exclusions.

You may qualify if:

• Capable of providing informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
• Adult female or male, 20-40 or 60-80 years of age, inclusive at time of screening.
• BMI ≥19.0 and ≤34.9 kg/m2, inclusive at time of screening.
• Stable weight (No gain/loss of ≥ 10 lbs within 6 months prior to screening).
• Non-smokers as defined by not smoked any tobacco or nicotine-containing products vape pens or vaporizers within 3 months prior to screening.

You may not qualify if:

• History of type 1 or type 2 diabetes per self-report at screening visit 1; or Hgb A1c ≥ 6.5% at screening..
• Actively pursuing weight loss and/or lifestyle changes at time of screening.
• Weight \> 450 lbs at screening.
• Uncontrolled hypertension (BP \>160 mmHg systolic or \>100 mmHg diastolic).
• Mini Mental State Exam (MMSE) \<21, only applicable for those 60-80 years of age
• Significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or evidence of cardiovascular disease assessed during the ECG at screening.
• Current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
• Prescription strength anti-inflammatory medication in the 6 weeks prior to screening.
• Surgery requiring \>2 days of hospitalization in the last 3 weeks prior to screening visit.
• Active malignancy or autoimmune disease.
• History of chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV, per self-report.
• History of uncontrolled severe diarrhea, nausea or vomiting within 3 months of screening.
• Uncontrolled severe (including stage III or above) gastrointestinal absorption-related disorders, within 3 months of screening, such as: obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome, gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
• History of drug or alcohol abuse (\> 3 drinks per day) within the last 5 years.
• Pregnant, lactating or is within 6 weeks postpartum prior to the screening visit.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (19)

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• Cypess AM, Lehman S, Williams G, Tal I, Rodman D, Goldfine AB, Kuo FC, Palmer EL, Tseng YH, Doria A, Kolodny GM, Kahn CR. Identification and importance of brown adipose tissue in adult humans. N Engl J Med. 2009 Apr 9;360(15):1509-17. doi: 10.1056/NEJMoa0810780.

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  PMID: 19357405 BACKGROUND

• Saito M, Okamatsu-Ogura Y, Matsushita M, Watanabe K, Yoneshiro T, Nio-Kobayashi J, Iwanaga T, Miyagawa M, Kameya T, Nakada K, Kawai Y, Tsujisaki M. High incidence of metabolically active brown adipose tissue in healthy adult humans: effects of cold exposure and adiposity. Diabetes. 2009 Jul;58(7):1526-31. doi: 10.2337/db09-0530. Epub 2009 Apr 28.

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• Stanford KI, Middelbeek RJ, Townsend KL, An D, Nygaard EB, Hitchcox KM, Markan KR, Nakano K, Hirshman MF, Tseng YH, Goodyear LJ. Brown adipose tissue regulates glucose homeostasis and insulin sensitivity. J Clin Invest. 2013 Jan;123(1):215-23. doi: 10.1172/JCI62308. Epub 2012 Dec 10.

  PMID: 23221344 BACKGROUND

• Berbee JF, Boon MR, Khedoe PP, Bartelt A, Schlein C, Worthmann A, Kooijman S, Hoeke G, Mol IM, John C, Jung C, Vazirpanah N, Brouwers LP, Gordts PL, Esko JD, Hiemstra PS, Havekes LM, Scheja L, Heeren J, Rensen PC. Brown fat activation reduces hypercholesterolaemia and protects from atherosclerosis development. Nat Commun. 2015 Mar 10;6:6356. doi: 10.1038/ncomms7356.

  PMID: 25754609 BACKGROUND

• Gunawardana SC, Piston DW. Reversal of type 1 diabetes in mice by brown adipose tissue transplant. Diabetes. 2012 Mar;61(3):674-82. doi: 10.2337/db11-0510. Epub 2012 Feb 7.

  PMID: 22315305 BACKGROUND

• Thoonen R, Ernande L, Cheng J, Nagasaka Y, Yao V, Miranda-Bezerra A, Chen C, Chao W, Panagia M, Sosnovik DE, Puppala D, Armoundas AA, Hindle A, Bloch KD, Buys ES, Scherrer-Crosbie M. Functional brown adipose tissue limits cardiomyocyte injury and adverse remodeling in catecholamine-induced cardiomyopathy. J Mol Cell Cardiol. 2015 Jul;84:202-11. doi: 10.1016/j.yjmcc.2015.05.002. Epub 2015 May 9.

  PMID: 25968336 BACKGROUND

• Stanford KI, Lynes MD, Takahashi H, Baer LA, Arts PJ, May FJ, Lehnig AC, Middelbeek RJW, Richard JJ, So K, Chen EY, Gao F, Narain NR, Distefano G, Shettigar VK, Hirshman MF, Ziolo MT, Kiebish MA, Tseng YH, Coen PM, Goodyear LJ. 12,13-diHOME: An Exercise-Induced Lipokine that Increases Skeletal Muscle Fatty Acid Uptake. Cell Metab. 2018 May 1;27(5):1111-1120.e3. doi: 10.1016/j.cmet.2018.03.020.

  PMID: 29719226 BACKGROUND

• Lynes MD, Leiria LO, Lundh M, Bartelt A, Shamsi F, Huang TL, Takahashi H, Hirshman MF, Schlein C, Lee A, Baer LA, May FJ, Gao F, Narain NR, Chen EY, Kiebish MA, Cypess AM, Bluher M, Goodyear LJ, Hotamisligil GS, Stanford KI, Tseng YH. The cold-induced lipokine 12,13-diHOME promotes fatty acid transport into brown adipose tissue. Nat Med. 2017 May;23(5):631-637. doi: 10.1038/nm.4297. Epub 2017 Mar 27.

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• Rothwell NJ, Stock MJ. Effects of age on diet-induced thermogenesis and brown adipose tissue metabolism in the rat. Int J Obes. 1983;7(6):583-9.

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• Lowell BB, S-Susulic V, Hamann A, Lawitts JA, Himms-Hagen J, Boyer BB, Kozak LP, Flier JS. Development of obesity in transgenic mice after genetic ablation of brown adipose tissue. Nature. 1993 Dec 23-30;366(6457):740-2. doi: 10.1038/366740a0.

  PMID: 8264795 BACKGROUND

• Bartelt A, Bruns OT, Reimer R, Hohenberg H, Ittrich H, Peldschus K, Kaul MG, Tromsdorf UI, Weller H, Waurisch C, Eychmuller A, Gordts PL, Rinninger F, Bruegelmann K, Freund B, Nielsen P, Merkel M, Heeren J. Brown adipose tissue activity controls triglyceride clearance. Nat Med. 2011 Feb;17(2):200-5. doi: 10.1038/nm.2297. Epub 2011 Jan 23.

  PMID: 21258337 BACKGROUND

• Guerra C, Koza RA, Yamashita H, Walsh K, Kozak LP. Emergence of brown adipocytes in white fat in mice is under genetic control. Effects on body weight and adiposity. J Clin Invest. 1998 Jul 15;102(2):412-20. doi: 10.1172/JCI3155.

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  PMID: 6713291 BACKGROUND

Related Links

• Translational Research Institute for Metabolism and Diabetes

MeSH Terms

Interventions

glycine N-choloyltransferase; X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Paul Coen, PhD

  Study principal investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 4, 2019
• Study Start: January 23, 2019
• Primary Completion: May 13, 2019
• Study Completion: December 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)