NCT04352244 The Physiology of Human Brown Adipose Tissue
| NCT ID | NCT04352244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Adipose Tissue, Brown |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-03-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2020-03-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion criteria: 1\. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC. Exclusion Criteria: 1. Body mass index (BMI) greater than or equal to 40 kg/m2 2. History of any local or systemic infectious disease with fever or requiring antibiotic within four weeks of drug administration; 3. Diabetes, either previously diagnosed or hemoglobin A1c greater than or equal to 6.5% 4. Use of oral or parenteral corticosteroids (epidural permitted) or other medication known to cause insulin resistance in the previous 6 weeks. 5. Willingness to provide informed consent and follow study procedures, including attending scheduled visits. 6. Chronic kidney disease stage 4 or 5 (including end-stage renal disease); 7. 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; 8. Active malignancy (except squamous or basal cell carcinoma of skin) 9. Bleeding disorder, treatment with anticoagulants (if not discontinued prior to surgery), or platelet count \<50,000; 10. Current addiction to alcohol or substances of abuse; 11. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation; 12. Use of an investigational drug within 30 days prior to screening. 13. 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. 14. Because the goal is to study adult human brown adipose tissue, children are not eligible to participate.
Contact & Investigator
Mary Elizabeth Patti, MD
PRINCIPAL INVESTIGATOR
Joslin Diabetes Center
Frequently Asked Questions
Who can join the NCT04352244 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Adipose Tissue, Brown. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04352244 currently recruiting?
Yes, NCT04352244 is actively recruiting participants. Contact the research team at MaryElizabeth.Patti@joslin.harvard.edu for enrollment information.
Where is the NCT04352244 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04352244 clinical trial?
NCT04352244 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Mary Elizabeth Patti, MD at Joslin Diabetes Center. The trial plans to enroll 40 participants.