Adipose Tissue, BrownNCT04352244
The Physiology of Human Brown Adipose Tissue
An observational study of Adipose Tissue, Brown and Adipose Tissue, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue, Brown, Adipose Tissue, Obesity
- What is being tested?
- Fat biopsy, Blood sampling and Blood sample for DNA analysis
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants planning a procedure will be recruited from clinical practices of Dr. Andrew White, Dr. Peter Mowschenson, and Dr. Per-Olof Hasselgren at BIDMC.
Who may be able to join
- 1. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC.
Who cannot join
- 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);
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Andrew P White, MD, 6177549000, apwhite@bidmc.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Adipose Tissue, Brown, Adipose Tissue, Obesity
- Being tested
- Fat biopsy, Blood sampling, Blood sample for DNA analysis
- Keywords
- Human Cell Atlas
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat biopsyProcedure or surgery
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 samplingDiagnostic 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 analysisGenetic
Targeted resequencing of DNA to identify variants associated with adipose phenotypes will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Participants | Individuals undergoing abdominal surgery or radiologically-guided biopsies for clinical indications will be recruited prior to the planned procedures. Receives: Procedure: Fat biopsy; Diagnostic Test: Blood sampling; Genetic: Blood sample for DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for single nucleus RNA analysis.
Adipose tissue biopsy samples will be processed for single-nucleus RNA analysis of gene expression.
Measured: March 2022
Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for Raman spectroscopy.
Adipose tissue biopsy samples will be processed for Raman spectroscopy analysis.
Measured: March 2022
Collect human brown and white adipose tissue to prepare cells for ex vivo differentiation
Adipose tissue biopsy samples will be processed for ex vivo differentiation.
Measured: March 2022
Insulin resistance
Insulin resistance of participants, assessed by homeostatic model of insulin resistance (HOMA-IR), will be analyzed and summarized.
Measured: March 2022
Hemoglobin A1c
Hemoglobin A1c levels for participants will be analyzed and summarized.
Measured: March 2022
Fasting glucose levels
Fasting glucose levels for participants will be analyzed and summarized.
Measured: March 2022
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2. BMI of participants will be analyzed and summarized.
Measured: March 2022
Demographic characteristics
Demographic characteristics of participants will be analyzed and summarized.
Measured: March 2022
Secondary outcomes (1)
DNA analysis
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).
Measured: March 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start5 Mar 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adipose Tissue, BrownStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Joslin Diabetes Center, Chan Zuckerberg Initiative
- Responsible party
- Principal investigator, Mary Elizabeth Patti, Beth Israel Deaconess Medical Center
- Investigators
- Mary Elizabeth Patti, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352244
- Sponsor's protocol ID
- 2009P-000101
- Status last verified
- Oct 2025
- First submitted
- 31 Mar 2020
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be shared with other researchers with permission of local institutional review boards via the Human Cell Atlas database.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiology of Human Brown Adipose Tissue
- ClinicalTrials.gov ID
- NCT04352244
- Acronym / sponsor ID
- 2009P-000101
- Conditions
- Adipose Tissue, Brown, Adipose Tissue, Obesity
- Keywords
- Human Cell Atlas
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Joslin Diabetes Center, Chan Zuckerberg Initiative
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Participants | – | Procedure: Fat biopsy, Diagnostic Test: Blood sampling, Genetic: Blood sample for DNA analysisIndividuals undergoing abdominal surgery or radiologically-guided biopsies for clinical indications will be recruited prior to the planned procedures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants planning a procedure will be recruited from clinical practices of Dr. Andrew White, Dr. Peter Mowschenson, and Dr. Per-Olof Hasselgren at BIDMC.
Key inclusion criteria (1 listed)
- 1. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat biopsyThe 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. | Procedure or surgery | Surgical Participants |
| Blood samplingA 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). | Diagnostic test | Surgical Participants |
| Blood sample for DNA analysisTargeted resequencing of DNA to identify variants associated with adipose phenotypes will be performed. | Genetic | Surgical Participants |
Primary outcome
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.
1 secondary outcome
DNA analysis
Time frame: March 2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be shared with other researchers with permission of local institutional review boards via the Human Cell Atlas database.
Related trials for Adipose Tissue, Brown
Not yet recruiting
Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women
Cardiometabolic Diseases, Postmenopause
RecruitingObservational study
Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
Brown Adipose Tissue (BAT) Physiology, Phenotyping
RecruitingPhase 2
Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence
Atrial Fibrillation (AF)
Recruiting
Brown Adipose Tissue Activation by Spinal Cord Stimulation
Pain, Back, Obesity, Morbid
Not yet recruiting
Brown Adipose Tissue as a Mechanistic Determinant of Semaglutide Treatment Response in Obesity (BAT-Sema Study)
Obesity, Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Elizabeth Patti, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adipose Tissue, Brown and Adipose Tissue, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Elizabeth Patti, MD (6173092635, MaryElizabeth.Patti@joslin.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.