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RecruitingNCT04352244Updated Oct 31, 2025

The Physiology of Human Brown Adipose Tissue

An observational study in Adipose Tissue, Brown, Adipose Tissue and Obesity, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-31.

Sponsored by Beth Israel Deaconess Medical Center · Observational

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 7 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 75 Years
Sex
All
01

Study 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 extra calories. Understanding more about differences between brown and white fat may allow us to develop new approaches to improve the body's metabolism.

Read the 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 chemical imaging, single-cell and single-nucleus RNA sequencing (sc and snRNAseq), and site-specific collection of adipocytes and adipocyte precursors.

Deidentified data from these studies will be submitted to the Human Cell Atlas. The investigators anticipate that these studies will ultimately increase understanding of mechanisms by which fat (adipose) tissue regulates systemic metabolism (energy transformation in the body), and promotes risk for metabolic disease. Knowledge gained from this research may be used to set the stage for disease-specific analyses, and aid in the development of personalized medicine for metabolic diseases such as type 2 diabetes.

02

Conditions studied

  • Adipose Tissue, Brown
  • Adipose Tissue
  • Obesity

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Keywords

  • Human Cell Atlas
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 40 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants planning a procedure will be recruited from clinical practices of Dr. Andrew White, Dr. Peter Mowschenson, and Dr. Per-Olof Hasselgren at BIDMC.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Surgical Participants

    Individuals undergoing abdominal surgery or radiologically-guided biopsies for clinical indications will be recruited prior to the planned procedures.

    Procedure: Fat biopsy · Diagnostic Test: Blood sampling · Genetic: Blood sample for DNA analysis

Interventions

  • ProcedureFat biopsy

    The fat biopsy is performed during a scheduled procedure at the Beth Israel Deaconess Medical Center (BIDMC). Routine preoperative procedures will be followed, including local anesthesia (numbing a particular region of the body) or general anesthesia (being put to sleep). Adipose tissue will be sampled from different depots depending on the procedure. For example, the surgeon will collect adipose tissue from the neck and supraclavicular depots from cervical spine, thyroid, and parathyroid procedures; perinephric fat from adrenalectomies, omental fat from abdominal procedures, and paraspinal fat from lumbar spine procedures. Up to 5 pieces of fat tissue weighing about three to six grams will be removed. All other aspects of the surgical procedure will proceed as planned. Samples will be prepared for subsequent laboratory analysis.

  • Diagnostic testBlood sampling

    A blood sample will be collected in the fasting state either during preoperative testing or in the preoperative area on the day of planned procedure for measurement of adipose functional markers (leptin, adiponectin) and insulin resistance (insulin, C-peptide), and measures of glycemia (glucose, hemoglobin A1c).

  • GeneticBlood sample for DNA analysis

    Targeted resequencing of DNA to identify variants associated with adipose phenotypes will be performed.

06

What researchers measure

Primary outcomes

  1. Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for single nucleus RNA analysis.

    Adipose tissue biopsy samples will be processed for single-nucleus RNA analysis of gene expression.

    Time frame: March 2022

  2. Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for Raman spectroscopy.

    Adipose tissue biopsy samples will be processed for Raman spectroscopy analysis.

    Time frame: March 2022

  3. Collect human brown and white adipose tissue to prepare cells for ex vivo differentiation

    Adipose tissue biopsy samples will be processed for ex vivo differentiation.

    Time frame: March 2022

  4. Insulin resistance

    Insulin resistance of participants, assessed by homeostatic model of insulin resistance (HOMA-IR), will be analyzed and summarized.

    Time frame: March 2022

  5. Hemoglobin A1c

    Hemoglobin A1c levels for participants will be analyzed and summarized.

    Time frame: March 2022

  6. Fasting glucose levels

    Fasting glucose levels for participants will be analyzed and summarized.

    Time frame: March 2022

  7. Body mass index (BMI)

    Weight and height will be combined to report BMI in kg/m\^2. BMI of participants will be analyzed and summarized.

    Time frame: March 2022

  8. Demographic characteristics

    Demographic characteristics of participants will be analyzed and summarized.

    Time frame: March 2022

Secondary outcomes

  1. DNA analysis

    DNA will be isolated and stored from blood samples. If specific genes are differentially regulated as a function of metabolic state or anatomical location of biopsy, locus-specific or genome-wide genotyping may be performed to assess potential regulatory single-nucleotide polymorphisms (SNP).

    Time frame: March 2022

07

Study locations

1 of 1 sites recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    Recruiting
08

References and documents

Study documents

  • Informed consent form · Dec 9, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Deidentified participant data will be shared with other researchers with permission of local institutional review boards via the Human Cell Atlas database.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04352244
Lead sponsor
Beth Israel Deaconess Medical Center
Collaborators
Joslin Diabetes Center, Chan Zuckerberg Initiative
Responsible party
Mary Elizabeth Patti (Associate Professor of Medicine, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Apr 20, 2020
Start date
Mar 5, 2020
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 31, 2025

Study contacts

Mary Elizabeth Patti, MD
Contact
MaryElizabeth.Patti@joslin.harvard.edu
6173092635
Amanda L Sheehan, MSN
Contact
amanda.sheehan@joslin.harvard.edu
6173092695
Mary Elizabeth Patti, MD
principal investigator · Joslin Diabetes Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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