NCT04352244 · Beth Israel Deaconess Medical Center
The Physiology of Human Brown Adipose Tissue
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
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.
DIAGNOSTIC_TEST
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).
GENETIC
Blood sample for DNA analysis
Targeted resequencing of DNA to identify variants associated with adipose phenotypes will be performed.
Primary outcome measures
Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for single nucleus RNA analysis.
Time frame: March 2022
Adipose tissue biopsy samples will be processed for single-nucleus RNA analysis of gene expression.
Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for Raman spectroscopy.
Time frame: March 2022
Adipose tissue biopsy samples will be processed for Raman spectroscopy analysis.
Collect human brown and white adipose tissue to prepare cells for ex vivo differentiation
Time frame: March 2022
Adipose tissue biopsy samples will be processed for ex vivo differentiation.
Insulin resistance
Time frame: March 2022
Insulin resistance of participants, assessed by homeostatic model of insulin resistance (HOMA-IR), will be analyzed and summarized.
Hemoglobin A1c
Time frame: March 2022
Hemoglobin A1c levels for participants will be analyzed and summarized.
Fasting glucose levels
Time frame: March 2022
Fasting glucose levels for participants will be analyzed and summarized.
Body mass index (BMI)
Time frame: March 2022
Weight and height will be combined to report BMI in kg/m\^2. BMI of participants will be analyzed and summarized.
Demographic characteristics
Time frame: March 2022
Demographic characteristics of participants will be analyzed and summarized.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Boston, Massachusetts
Collaborators
Joslin Diabetes Center, Chan Zuckerberg Initiative
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 31, 2025 · Source of record for eligibility and locations