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.

Who can participate

Age range

65 Years – 90 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

. History of type 1 or type 2 diabetes per self-report at screening visit 1.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Collection of Imaging of BAT by Magnetic Resonance Imaging

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

Trial details

NCT IDNCT04168580

SponsorAdventHealth Translational Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-23

Results submitted2025-06-06

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