Clincosm LogoSign in Get a demo

BATSP: Brown Adipose Tissue Pilot

Sponsor
AdventHealth Translational Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03793127
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
43.3
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Maximal oxygen consumption (V02 max)
  • Other: Brown adipose tissue (BAT) imaging
  • Other: Muscle function testing
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a single site cross sectional study.This is a single site cross sectional study.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
BAT as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence Pilot
Actual Study Start Date :
Jan 23, 2019
Actual Primary Completion Date :
May 13, 2019
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Young group

20-40 years of age

Other: Maximal oxygen consumption (V02 max)
Aerobic fitness will be determined by measuring V02 max during a stationary bicycle exercise test.

Other: Brown adipose tissue (BAT) imaging
Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method.

Other: Muscle function testing
This test will be done on a machine called a Biodex. We will measure the speed at which subjects move resistance at different percentages of their peak strength.
Other: Old group

60-80 years of age

Other: Maximal oxygen consumption (V02 max)
Aerobic fitness will be determined by measuring V02 max during a stationary bicycle exercise test.

Other: Brown adipose tissue (BAT) imaging
Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method.

Other: Muscle function testing
This test will be done on a machine called a Biodex. We will measure the speed at which subjects move resistance at different percentages of their peak strength.

Outcome Measures

Primary Outcome Measures

  1. Collection of imaging of BAT by magnetic resonance imaging from 10 participants in each of young and old study groups. [30 minutes]

    Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method. The participant may be removed from the magnet and repositioned during the exam in order to determine the same day variability of this method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Translational Research Institute for Metabolism and Diabetes Orlando Florida United States 32804

Sponsors and Collaborators

  • AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Paul Coen, PhD, Study principal investigator

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier:
NCT03793127
Other Study ID Numbers:
  • TRIMD 1344107
First Posted:
Jan 4, 2019
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 6, 2021