Brown Adipose Tissue Pilot



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:20 - 80
Updated:2/17/2019
Start Date:January 23, 2019
End Date:May 2019
Contact:Recruitment Department
Email:tri@flhosp.org
Phone:407-303-7100

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


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.
We found this trial at
1
site
Orlando, Florida 32804
Principal Investigator: Paul Coen, PhD
?
mi
from
Orlando, FL
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