Recruiting

Observational Study

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT04352244

Conditions

Adipose Tissue, Brown

Adipose Tissue

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Fat biopsy

Blood sampling

Blood sample for DNA analysis

Study Details

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

Study ID

NCT04352244

Start date

Mar 5, 2020

Status verified date

Oct, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical Participants

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

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.

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).

Blood sample for DNA analysis

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

Primary outcome measure

  • Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for single nucleus RNA analysis. [ Time Frame: March 2022 ]
  • Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for Raman spectroscopy. [ Time Frame: March 2022 ]
  • Collect human brown and white adipose tissue to prepare cells for ex vivo differentiation [ Time Frame: March 2022 ]
  • Insulin resistance [ Time Frame: March 2022 ]
  • Hemoglobin A1c [ Time Frame: March 2022 ]
  • Fasting glucose levels [ Time Frame: March 2022 ]
  • Body mass index (BMI) [ Time Frame: March 2022 ]
  • Demographic characteristics [ Time Frame: March 2022 ]

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • Human Cell Atlas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-10-31.