The Physiology of Human Brown Adipose Tissue

NCT04352244 | Recruiting DMC

• 1 other identifier: 2009P-000101
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adipose Tissue, Brown; Adipose Tissue; Obesity

Keywords

Human Cell Atlas

Outcome Measures

Primary Outcomes (8)

• 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.

  March 2022

• 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.

  March 2022

• 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.

  March 2022

• Insulin resistance

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

  March 2022

• Hemoglobin A1c

  Hemoglobin A1c levels for participants will be analyzed and summarized.

  March 2022

• Fasting glucose levels

  Fasting glucose levels for participants will be analyzed and summarized.

  March 2022

• 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.

  March 2022

• Demographic characteristics

  Demographic characteristics of participants will be analyzed and summarized.

  March 2022

Secondary Outcomes (1)

• DNA analysis

  March 2022

Study Arms (1)

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

Fat biopsy 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.

Surgical Participants

Blood sampling 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).

Surgical Participants

Blood sample for DNA analysis GENETIC

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

Surgical Participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Joslin Diabetes Center: collaborator
• Chan Zuckerberg Initiative: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Specimens to be retained: blood and adipose tissue samples.

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mary Elizabeth Patti, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Elizabeth Patti, MD

CONTACT

6173092635; MaryElizabeth.Patti@joslin.harvard.edu

Amanda L Sheehan, MSN

CONTACT

6173092695; amanda.sheehan@joslin.harvard.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 20, 2020
• Study Start: March 5, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication of study results
• Access Criteria: Data will be shared with academic investigators with approval of local institutional review boards.

Locations

US (1)