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 range20 Years – 80 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.
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…
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