The Physiology of Human Brown Adipose Tissue
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fat biopsy, Blood sampling, Blood sample for DNA analysis.
- Who it may be relevant to
- Registry conditions: Adipose Tissue, Brown, Adipose Tissue, Obesity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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 proce - 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]
- 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]
Secondary outcome measures (1)
- DNA analysis [Time frame: March 2022]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Beth Israel Deaconess Medical Center — Boston
Identifiers
NCT: NCT04352244 · 2009P-000101