Clinical trial

The Physiology of Human Brown Adipose Tissue

Recruiting now · Not applicable · 1 countries · Registry ID NCT04352244

Recruiting nowNot applicableObservational

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersAccepted
ConditionAdipose Tissue, Brown, Adipose Tissue, Obesity

Full registry 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.

Treatments and study arms

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.

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).

Blood sample for DNA analysis

Genetic

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

Primary outcomes

Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for single nucleus RNA analysis.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.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 differentiationMarch 2022

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

Insulin resistanceMarch 2022

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

Hemoglobin A1cMarch 2022

Hemoglobin A1c levels for participants will be analyzed and summarized.

Fasting glucose levelsMarch 2022

Fasting glucose levels for participants will be analyzed and summarized.

Body mass index (BMI)March 2022

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

Demographic characteristicsMarch 2022

Demographic characteristics of participants will be analyzed and summarized.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Beth Israel Deaconess Medical Center🇺🇸 Boston, Massachusetts, United States
Andrew P White, MDContact