Mapping human brown fat to understand metabolism

The Physiology of Human Brown Adipose Tissue

This study is trying to learn more about the differences between brown and white fat in people to see how they affect metabolism and help with conditions like type 2 diabetes.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04352244 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the differences between brown and white adipose tissue in humans. Researchers will utilize advanced techniques such as quantitative chemical imaging and single-cell RNA sequencing to analyze fat cells and their precursors. The goal is to enhance understanding of how adipose tissue influences metabolism and contributes to metabolic diseases. Data collected will be shared with the Human Cell Atlas to support further research in personalized medicine for conditions like type 2 diabetes.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 75 who are undergoing a planned clinical procedure.

Not a fit: Patients with a BMI of 40 kg/m2 or higher, diabetes, or significant liver or kidney disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to new strategies for improving metabolism and treating metabolic diseases.

How similar studies have performed: While the approach of mapping adipose tissue is innovative, similar studies have shown promise in understanding metabolic diseases.

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.

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Mary Elizabeth Patti, MD — Joslin Diabetes Center
• Study coordinator: Mary Elizabeth Patti, MD

Conditions: Adipose Tissue, Brown, Adipose Tissue, Obesity, Human Cell Atlas