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OpenTrials
Active, Not Recruiting

NCT Number: NCT03793127

Brown Adipose Tissue Pilot

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening.
  • Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at screening.
  • Unable to tolerate MRI imaging or claustrophobia.
  • Urine albumin-to-creatinine ratio (UACR) ≥300 mg/g in a single urine specimen (per National Kidney Foundation guideline) at screening.
  • Impaired renal function: estimated glomerular filtration rate (eGFR) ≤ 50 ml/min/1.73m2 determined at screening.
  • Significantly impaired liver function in the opinion of the study PI (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥2.5 times normal limit at time of screening.
  • Total cholesterol level is ˃300 mg/dL at screening.
  • Participant has inadequately treated hyperthyroidism (thyroid stimulating hormone [TSH] below normal range) or hypothyroidism (TSH>ULN (upper limit normal) to <10U/mL and symptomatic, or TSH >10 U/mL) at time of screening.

Treatment and study plan

Maximal oxygen consumption (V02 max)

Other

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

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.

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.

Primary outcomes

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

    Time frame: 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Registry information

Official study title

BAT as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence Pilot

Acronym: BATSP

Important dates

Study start
2019
Primary completion
2019
Study completion
2025
First posted
Jan 4, 2019
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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