RecruitingNot Applicable

The Physiology of Human Brown Adipose Tissue

United States40 participantsStarted 2020-03-05

Plain-language 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. Understanding more about differences between brown and white fat may allow us to develop new approaches to improve the body's metabolism.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: March 2022

Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for Raman spectroscopy.

Timeframe: March 2022

Collect human brown and white adipose tissue to prepare cells for ex vivo differentiation

Timeframe: March 2022

Insulin resistance

Timeframe: March 2022

Hemoglobin A1c

Timeframe: March 2022

Fasting glucose levels

Timeframe: March 2022

Body mass index (BMI)

Timeframe: March 2022

Trial details

NCT IDNCT04352244

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-30

Contact for this trial

Mary Elizabeth Patti, MD

6173092635 MaryElizabeth.Patti@joslin.harvard.edu

View on ClinicalTrials.gov More Adipose Tissue, Brown trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

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

Timeframe: March 2022

Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for Raman spectroscopy.

Timeframe: March 2022

Collect human brown and white adipose tissue to prepare cells for ex vivo differentiation

Timeframe: March 2022

Insulin resistance

Timeframe: March 2022

Hemoglobin A1c

Timeframe: March 2022

Fasting glucose levels

Timeframe: March 2022

Body mass index (BMI)

Timeframe: March 2022