The Physiology of Human Brown Adipose Tissue

NCT ID: NCT04352244

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2027-06-30

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

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.

Conditions

Adipose Tissue, Brown; Adipose Tissue; Obesity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Surgical Participants

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

Fat biopsy

Intervention Type: PROCEDURE

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.

Blood sampling

Intervention Type: DIAGNOSTIC_TEST

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).

Blood sample for DNA analysis

Intervention Type: GENETIC

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

Interventions

Fat 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.

Intervention Type: PROCEDURE

Blood 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).

Intervention Type: DIAGNOSTIC_TEST

Blood sample for DNA analysis

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

Intervention Type: GENETIC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Joslin Diabetes Center

OTHER

Sponsor Role: collaborator

Chan Zuckerberg Initiative

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mary Elizabeth Patti

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Elizabeth Patti, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Elizabeth Patti, MD

Role: CONTACT

MaryElizabeth.Patti@joslin.harvard.edu

6173092635

Amanda L Sheehan, MSN

Role: CONTACT

amanda.sheehan@joslin.harvard.edu

6173092695

Facility Contacts

Andrew P White, MD

Role: primary

apwhite@bidmc.harvard.edu

6177549000

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2009P-000101

Identifier Type: -

Identifier Source: org_study_id