Brown Adipose Tissue Pilot (NCT03793127) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Brown Adipose Tissue Pilot
United States24 participantsStarted 2019-01-23
Plain-language 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.
Who can participate
Age range
20 Years – 80 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:
* 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…
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
1
Collection of imaging of BAT by magnetic resonance imaging from 10 participants in each of young and old study groups.
Timeframe: 30 minutes
Trial details
NCT IDNCT03793127
SponsorAdventHealth Translational Research Institute