The Physiology of Human Brown Adipose Tissue
Brown fat is a type of fat, found in both children and adults, which can produce heat and regulate the body's metabolism and energy use. White fat is the more common type of fat which is used to store extra calories. Understanding more about differences between brown and white fat may allow us to develop new approaches to improve the body's metabolism.
Conditions:
🦠 Adipose Tissue, Brown 🦠 Adipose Tissue 🦠 Obesity
🗓️ Study Start (Actual) 5 March 2020
🗓️ Primary Completion (Estimated) March 2024
✅ Study Completion (Estimated) March 2024
👥 Enrollment (Estimated) 40
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC.

    Exclusion Criteria:

    • 1. Body mass index (BMI) greater than or equal to 40 kg/m2
    • 2. History of any local or systemic infectious disease with fever or requiring antibiotic within four weeks of drug administration;
    • 3. Diabetes, either previously diagnosed or hemoglobin A1c greater than or equal to 6.5%
    • 4. Use of oral or parenteral corticosteroids (epidural permitted) or other medication known to cause insulin resistance in the previous 6 weeks.
    • 5. Willingness to provide informed consent and follow study procedures, including attending scheduled visits.
    • 6. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
    • 7. Hepatic disease, including serum alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
    • 8. Active malignancy (except squamous or basal cell carcinoma of skin)
    • 9. Bleeding disorder, treatment with anticoagulants (if not discontinued prior to surgery), or platelet count \<50,000;
    • 10. Current addiction to alcohol or substances of abuse;
    • 11. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation;
    • 12. Use of an investigational drug within 30 days prior to screening.
    • 13. There will be no involvement of special vulnerable populations such as fetuses, neonates, pregnant women, children, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
    • 14. Because the goal is to study adult human brown adipose tissue, children are not eligible to participate.
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 March 2020
  • First Submitted that Met QC Criteria 15 April 2020
  • First Posted 20 April 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 July 2023
  • Last Update Posted 12 July 2023
  • Last Verified July 2023