The Physiology of Human Brown Adipose Tissue
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|ClinicalTrials.gov Identifier: NCT04352244|
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : August 19, 2021
|Condition or disease||Intervention/treatment|
|Adipose Tissue, Brown Adipose Tissue Obesity||Procedure: Fat biopsy Diagnostic Test: Blood sampling Genetic: Blood sample for DNA analysis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||The Physiology of Human Brown Adipose Tissue|
|Actual Study Start Date :||March 5, 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Individuals undergoing abdominal surgery or radiologically-guided biopsies for clinical indications will be recruited prior to the planned procedures.
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.
- 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.
- DNA analysis [ Time Frame: March 2022 ]DNA will be isolated and stored from blood samples. If specific genes are differentially regulated as a function of metabolic state or anatomical location of biopsy, locus-specific or genome-wide genotyping may be performed to assess potential regulatory single-nucleotide polymorphisms (SNP).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352244
|Contact: Mary Elizabeth Patti, MD||6173092635||MaryElizabeth.Patti@joslin.harvard.edu|
|Contact: Amanda L Sheehan, MSNfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Andrew P White, MD 617-754-9000 email@example.com|
|Principal Investigator:||Mary Elizabeth Patti, MD||Joslin Diabetes Center|