CompletedNot Applicable

Brown Adipose Tissue as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence (BATSR)

United States32 participantsStarted 2020-10-20

Plain-language summary

The goal of this study is to define the effect of aging on brown adipose tissue mass in a cohort of older sedentary and older athlete adults.

Age range65 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males and Females between the ages of 65 to 90 years of age.
✓. BMI 35kg/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 smoking any tobacco or using nicotine-containing products and not using vape pens or vaporizers within 3 months prior to screening.
✓. Participant must have renal function with an estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2 determined at screening.
✓. Triglyceride level is \< 350 mg/dl and LDL cholesterol is ≤ 150 mg/dl at screening.
✓. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.
✓. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

✕. History of type 1 or type 2 diabetes per self-report at screening visit 1.
✕. Actively pursuing weight loss and/or lifestyle changes at time of screening.
✕. Untreated or poorly controlled hypertension (Systolic \> 150, Diastolic \> 95).
✕. Mini Mental State Exam (MMSE) \<21.
✕. Participant has had a significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of cardiovascular disease assessed during the ECG at screening. In the event of a positive stress test, participants are referred to their primary care physician. If the electrocardiogram (ECG) is determined to be a false positive, participant may be allowed to participate in study after confirmatory records obtained.
✕. 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.
✕. Participant is currently taking anti-inflammatory medication or has had anti-inflammatory medication within 1 week prior to screening (including over the counter formulations; e.g. Aleve, Motrin, ibuprofen, naproxen, low dose aspirin).
✕. Surgery requiring \>2 days of hospitalization in the last 3 weeks prior to screening visit.

Collection of Imaging of BAT by Magnetic Resonance Imaging

Timeframe: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)

NCT IDNCT04168580

SponsorAdventHealth Translational Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-23

Results submitted2025-06-06

Who can participate

Age range65 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males and Females between the ages of 65 to 90 years of age.
✓. BMI 35kg/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 smoking any tobacco or using nicotine-containing products and not using vape pens or vaporizers within 3 months prior to screening.
✓. Participant must have renal function with an estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2 determined at screening.
✓. Triglyceride level is \< 350 mg/dl and LDL cholesterol is ≤ 150 mg/dl at screening.
✓. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.
✓. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

✕. History of type 1 or type 2 diabetes per self-report at screening visit 1.
✕. Actively pursuing weight loss and/or lifestyle changes at time of screening.
✕. Untreated or poorly controlled hypertension (Systolic \> 150, Diastolic \> 95).
✕. Mini Mental State Exam (MMSE) \<21.
✕. Participant has had a significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of cardiovascular disease assessed during the ECG at screening. In the event of a positive stress test, participants are referred to their primary care physician. If the electrocardiogram (ECG) is determined to be a false positive, participant may be allowed to participate in study after confirmatory records obtained.
✕. 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.
✕. Participant is currently taking anti-inflammatory medication or has had anti-inflammatory medication within 1 week prior to screening (including over the counter formulations; e.g. Aleve, Motrin, ibuprofen, naproxen, low dose aspirin).
✕. Surgery requiring \>2 days of hospitalization in the last 3 weeks prior to screening visit.