Brown Adipose Tissue (BAT) PhysiologyNCT02692885
Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
An observational study of Brown Adipose Tissue (BAT) Physiology and Phenotyping, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: The body uses energy from calories for basic functions like breathing and digesting food. Over time, when a person eats more calories than they burn, they may become overweight or obese. Obesity is a major health concern. Researchers want to look at fat and muscle tissue to learn more about metabolism. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Brown Adipose Tissue (BAT) Physiology, Phenotyping, Brown Adipocytes
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2016to 31 Oct 2026
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two cohorts will be studied in this protocol, patients undergoing clinically-indicated surgery (Cohort 1) and healthy volunteers (Cohort 2).
Who may be able to join
- Male or female
- Any ethnicity
- 18 years or older
- Subject undergoing planned, clinically-indicated surgical procedure at the NIH Clinical Center in which tissue will be accessible and available for collection by the Operating Surgeon.
- Male or female
- Any ethnicity
- 18-80 year
- For supraclavicular or dorsocervical adipose biopsy: 18F-FDG PET/CT Scan images available in the CRC PACS system (performed as part of separate protocol)
Who cannot join
- Inability to provide consent.
- Pregnancy
- INCLUSION/EXCLUSION CRITERIA FOR ALL OTHER SUBJECTS (HEALTHY VOLUNTEERS AND NON-SURGICAL PATIENTS (COHORT 2):
- History of keloids.
- Currently taking blood thinning or anti-inflammatory medications including anti-platelet or antithrombotic medications.
- Pregnancy
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- History of pacemaker, metallic heart valves, aneurysm clip, pedicle screws, metallic foreign body in eye, or other metallic implant only if using fusion technology for the biopsy procedure.
- Psychological conditions including (but not limited to) clinical depression, bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study.
- Addiction to alcohol or substances of abuse within the last 5 years; current use of drugs or alcohol (CAGE greater than or equal to 2).
- Inability to provide consent.
- All subjects will be fully informed of the aims, nature, and risks of the study prior to giving written informed consent.
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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: The Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
Background:
The body uses energy from calories for basic functions like breathing and digesting food. Over time, when a person eats more calories than they burn, they may become overweight or obese. Obesity is a major health concern. Researchers want to look at fat and muscle tissue to learn more about metabolism. That is how the body uses food and other nutrients for normal function and energy. This research may help to develop new treatments for obesity and related diseases.
Read more
Objective:
To learn more about the role of fat and muscle in metabolism, particularly how fat and muscle store and use energy.
Eligibility:
Adults 18 years and older who have a planned surgery at NIH in which tissue can be collected by the surgeon.
Design:
Participants will be screened by their regular NIH doctor. Then researchers will contact them about this study.
Participants will not have to make extra visits to NIH for this study.
Researchers will collect samples during the participant s surgery. These will be fat tissue and skeletal muscle tissue. Muscle tissue will only be taken from tissue that is going to be discarded. Collecting the tissue will not add any time or any extra incisions than what is required for the surgery.
After surgery, blood will be drawn. Some participants will have this done in the pre-op or post-op room. Others will have this done during their hospital stay.
Read the detailed description
More than ever before, people are eating more calories from food than what they are burning off through exercise and other activities, and this imbalance is causing the rising rates of obesity and diabetes in the US and throughout the world. The different types of body fat are central players in this process. The white fat stores excess calories coming from food, while brown fat - also known as brown adipose tissue, or BAT - consumes the energy from food to generate heat. This important process in BAT is achieved through the action of a special protein found only in BAT, called uncoupling protein 1 (UCP1). Scientists used to believe that BAT was important only in small animals and human infants, but it was recently discovered by us and others that in response to mild cold exposure, adult human BAT (hBAT) consumes more glucose by weight than any other tissue. In addition, human BAT may also combat weight gain by becoming more active in the setting of increased food consumption. This phenomenon has already been demonstrated in mice and rats, and its presence suggests that activation of human BAT could be used as a safe treatment for obesity and metabolic disease. Finally, emerging evidence indicates that human BAT may be an endocrine organ, which means that it releases hormones into the blood and regulates other organs of the body as well, including skeletal muscle, liver, and the insulin-releasing pancreatic Beta-cell. If we are going to understand how hBAT functions in the body physiology and use its calorie-burning ability to treat illnesses of metabolism such as diabetes, we will need to approach the challenge using several different methods. One key reason is that BAT is not easy to find in the body, and the cells that make it up are different depending on where they are and what the body needs. Brown fat is composed of at least two known types of distinct cells, termed "constitutive"/brown and "inducible"/beige; and there are also white fat cells in varying proportions. Given that there is currently no known way to estimate the amount of brown fat in the body from a simple blood test, our lab group has successfully relied on collecting small amounts of fat from the site of surgery in patients who are already undergoing clinically indicated procedures. Information obtained from these fat tissues has addressed questions related to (a) how brown fat cells develop from immature stem cells; (b) what genes are active; and (c) how many calories the brown fat can burn. These earlier studies have also provided the preliminary cells necessary for establishing long-lasting human brown and white cells that can be grown indefinitely in the laboratory. Despite this progress, much remains unknown about the functional differences between brown and beige fat cells and how these could affect metabolism in humans of different age, sex, and genetic backgrounds, as well as the changes seen in the brown fat cells in different illnesses. The goal of this study is to address these and related questions.
- Keywords
- Phenotype, Adipose Tissue, Brown Adipose Tissue, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Individuals known to have brown adipose tissue, identified by PET/CT following participation/scanning in other clinical studies | |
| Surgical Patients | Individuals undergoing planned, clinically-indicated surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a comprehensive genetic and functional map of human brown and white adipose tissue.
To understand the physiology of human BAT and its role in metabolism.
Measured: tissue is collected the day of procedure/surgery
Determine which anthropometric and genetic factors influence the growth and function of human BAT.
To understand the physiology of human BAT and its role in metabolism.
Measured: tissue is collected the day of procedure/surgery
Identify factors within adipose tissue and plasma that (a) stimulate BAT growth and/or activity and/or (b) are released by BAT to regulate metabolism.
To understand the physiology of human BAT and its role in metabolism.
Measured: tissue is collected the day of procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start22 Mar 2016
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brown Adipose Tissue (BAT) PhysiologyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Aaron M Cypess, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692885
- Sponsor's protocol ID
- 160068
- Other IDs
- 16-DK-0068
- Status last verified
- 16 Sep 2026
- First submitted
- 25 Feb 2016
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
- ClinicalTrials.gov ID
- NCT02692885
- Acronym / sponsor ID
- 160068
- Keywords
- Phenotype, Adipose Tissue, Brown Adipose Tissue, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 Feb 2016 (estimated)
- 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.
Background:
The body uses energy from calories for basic functions like breathing and digesting food. Over time, when a person eats more calories than they burn, they may become overweight or obese. Obesity is a major health concern. Researchers want to look at fat and muscle tissue to learn more about metabolism. That is how the body uses food and other nutrients for normal function and energy. This research may help to develop new treatments for obesity and related diseases.
Objective:
To learn more about the role of fat and muscle in metabolism, particularly how fat and muscle store and use energy.
Eligibility:
Adults 18 years and older who have a planned surgery at NIH in which tissue can be collected by the surgeon.
Design:
Participants will be screened by their regular NIH doctor. Then researchers will contact them about this study.
Participants will not have to make extra visits to NIH for this study.
Researchers will collect samples during the participant s surgery. These will be fat tissue and skeletal muscle tissue. Muscle tissue will only be taken from tissue that is going to be discarded. Collecting the tissue will not add any time or any extra incisions than what is required for the surgery.
After surgery, blood will be drawn. Some participants will have this done in the pre-op or post-op room. Others will have this done during their hospital stay.
Detailed description
More than ever before, people are eating more calories from food than what they are burning off through exercise and other activities, and this imbalance is causing the rising rates of obesity and diabetes in the US and throughout the world. The different types of body fat are central players in this process. The white fat stores excess calories coming from food, while brown fat - also known as brown adipose tissue, or BAT - consumes the energy from food to generate heat. This important process in BAT is achieved through the action of a special protein found only in BAT, called uncoupling protein 1 (UCP1). Scientists used to believe that BAT was important only in small animals and human infants, but it was recently discovered by us and others that in response to mild cold exposure, adult human BAT (hBAT) consumes more glucose by weight than any other tissue. In addition, human BAT may also combat weight gain by becoming more active in the setting of increased food consumption. This phenomenon has already been demonstrated in mice and rats, and its presence suggests that activation of human BAT could be used as a safe treatment for obesity and metabolic disease. Finally, emerging evidence indicates that human BAT may be an endocrine organ, which means that it releases hormones into the blood and regulates other organs of the body as well, including skeletal muscle, liver, and the insulin-releasing pancreatic Beta-cell. If we are going to understand how hBAT functions in the body physiology and use its calorie-burning ability to treat illnesses of metabolism such as diabetes, we will need to approach the challenge using several different methods. One key reason is that BAT is not easy to find in the body, and the cells that make it up are different depending on where they are and what the body needs. Brown fat is composed of at least two known types of distinct cells, termed "constitutive"/brown and "inducible"/beige; and there are also white fat cells in varying proportions. Given that there is currently no known way to estimate the amount of brown fat in the body from a simple blood test, our lab group has successfully relied on collecting small amounts of fat from the site of surgery in patients who are already undergoing clinically indicated procedures. Information obtained from these fat tissues has addressed questions related to (a) how brown fat cells develop from immature stem cells; (b) what genes are active; and (c) how many calories the brown fat can burn. These earlier studies have also provided the preliminary cells necessary for establishing long-lasting human brown and white cells that can be grown indefinitely in the laboratory. Despite this progress, much remains unknown about the functional differences between brown and beige fat cells and how these could affect metabolism in humans of different age, sex, and genetic backgrounds, as well as the changes seen in the brown fat cells in different illnesses. The goal of this study is to address these and related questions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Individuals known to have brown adipose tissue, identified by PET/CT following participation/scanning in other clinical studies |
| Surgical Patients | – | –Individuals undergoing planned, clinically-indicated surgeries |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two cohorts will be studied in this protocol, patients undergoing clinically-indicated surgery (Cohort 1) and healthy volunteers (Cohort 2).
Key inclusion criteria (8 listed)
- Male or female
- Any ethnicity
- 18 years or older
- Subject undergoing planned, clinically-indicated surgical procedure at the NIH Clinical Center in which tissue will be accessible and available for collection by the Operating Surgeon.
- Male or female
Key exclusion criteria (11 listed)
- Inability to provide consent.
- Pregnancy
- INCLUSION/EXCLUSION CRITERIA FOR ALL OTHER SUBJECTS (HEALTHY VOLUNTEERS AND NON-SURGICAL PATIENTS (COHORT 2):
- History of keloids.
- Currently taking blood thinning or anti-inflammatory medications including anti-platelet or antithrombotic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish a comprehensive genetic and functional map of human brown and white adipose tissue.
Time frame: tissue is collected the day of procedure/surgery
To understand the physiology of human BAT and its role in metabolism.
Determine which anthropometric and genetic factors influence the growth and function of human BAT.
Time frame: tissue is collected the day of procedure/surgery
To understand the physiology of human BAT and its role in metabolism.
Identify factors within adipose tissue and plasma that (a) stimulate BAT growth and/or activity and/or (b) are released by BAT to regulate metabolism.
Time frame: tissue is collected the day of procedure/surgery
To understand the physiology of human BAT and its role in metabolism.
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 22 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
Related trials for Brown Adipose Tissue (BAT) Physiology
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Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women
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Cold Acclimation as a Modulator of Brown Adipose Tissue Function in Adults With Obesity
Obesity
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Food Intake, Endocrine Factors and Brown Fat
Obesity
RecruitingObservational study
The Physiology of Human Brown Adipose Tissue
Adipose Tissue, Brown, Adipose Tissue
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.
Aaron M Cypess, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Brown Adipose Tissue (BAT) Physiology and Phenotyping, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 8 inclusion and 11 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 22 Sep 2026. 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 Ashley M Schmitz, C.R.N.P. ((920) 948-1186, ashley.schmitz@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a comprehensive genetic and functional map of human brown and white adipose tissue. (time frame: tissue is collected the day of procedure/surgery). The study lists 3 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 22 Sep 2026.