Status:

RECRUITING

The Physiology of Human Brown Adipose Tissue

Lead Sponsor:

Beth Israel Deaconess Medical Center

Collaborating Sponsors:

Joslin Diabetes Center

Chan Zuckerberg Initiative

Conditions:

Adipose Tissue, Brown

Adipose Tissue

Eligibility:

All Genders

18-75 years

Brief Summary

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...

Detailed Description

The overarching goal of this study, is to map fat (adipose) tissue differences in humans. The investigators will probe multiple aspects of fat cell (adipocyte) identity by integrating quantitative che...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • 1\. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC.
  • Exclusion Criteria:
  • Body mass index (BMI) greater than or equal to 40 kg/m2
  • History of any local or systemic infectious disease with fever or requiring antibiotic within four weeks of drug administration;
  • Diabetes, either previously diagnosed or hemoglobin A1c greater than or equal to 6.5%
  • Use of oral or parenteral corticosteroids (epidural permitted) or other medication known to cause insulin resistance in the previous 6 weeks.
  • Willingness to provide informed consent and follow study procedures, including attending scheduled visits.
  • Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
  • 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;
  • Active malignancy (except squamous or basal cell carcinoma of skin)
  • Bleeding disorder, treatment with anticoagulants (if not discontinued prior to surgery), or platelet count \<50,000;
  • Current addiction to alcohol or substances of abuse;
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation;
  • Use of an investigational drug within 30 days prior to screening.
  • 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.
  • Because the goal is to study adult human brown adipose tissue, children are not eligible to participate.

Exclusion

    Key Trial Info

    Start Date :

    March 5 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2027

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT04352244

    Start Date

    March 5 2020

    End Date

    June 30 2027

    Last Update

    October 31 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States, 02215