Identifying factors that silence brown fat activation in humans

Identification of Thermogenic Silencing Regulatory Factors as Biomarkers of Metabolic Health in Humans

This study is testing how cold exposure and fasting affect brown fat activity in people to see if it can help with obesity and metabolic health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 35 Years
• Sex: All
• Sponsor: Rockefeller University (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06424132 on ClinicalTrials.gov

What this trial studies

This study aims to explore the mechanisms that silence non-shivering thermogenesis (NST) in human brown fat, which is crucial for addressing obesity and metabolic diseases. By exposing participants to cold and rewarming periods, along with fasting, researchers will investigate how these conditions affect brown fat activity. The goal is to identify regulatory factors that inhibit NST, which could lead to new therapeutic strategies for enhancing energy expenditure and improving metabolic health. This research is significant as it seeks to unlock the potential of brown fat in combating obesity and related disorders.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 35 with either a lean BMI (18.5-24.9) or an obese BMI (>30), including those with type 2 diabetes.

Not a fit: Patients with type 1 diabetes, thyroid disease, cancer, or recent COVID-19 diagnosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to novel treatments that enhance brown fat activation, improving metabolic health and aiding in obesity management.

How similar studies have performed: While many studies have explored brown fat activation, this approach to identifying silencing factors is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 years old and 35
2. Lean group: BMI is between 18.5 and 24.9. HgA1c \<5.7%
3. Obese group: BMI is \>30, HgA1c \<5.7%
4. Obese group with Type II diabetes: BMI is \>30, HgA1c is \>6.5% If on oral medication for diabetes management, HgA1c may be \< 6.5% The following medications are also acceptable: statins, aspirin, angiotensin-converting enzyme inhibitors (ACEi), and angiotensin receptor blockers (ARB).

Exclusion Criteria:

1. Diabetes type I (self-report)
2. Diagnosis of thyroid disease (including goiter, hyperthyroidism, hypothyroidism, thyroiditis)(self-report)
3. Diagnosis with cancer including skin cancer (self-report)
4. Diagnosis or evidence of Raynaud's Syndrome or systemic sclerosis (self-report)
5. A recent diagnosis of Coronavirus Disease 2019 (COVID-19) (last 2 weeks) or hospitalized at the time of diagnosis with COVID-19
6. Any vaccine administration within two weeks preceding the study procedure
7. Currently pregnant
8. Currently taking any prescribed medication other than oral contraceptives. Treatments for weight loss or any other supplements that may alter weight or metabolism are not acceptable. Vitamins are acceptable.
9. Has consumed nicotine (smoking, inhaling, ingesting) within the last 6 months
10. Has used illicit drugs within the last 6 months (marijuana users are eligible unless consumed in the last 30 days).
11. Any medical, psychological, or social condition that, in opinion of principle investigators, would jeopardize the health or well-being of the participant during the study procedure or the integrity of the data
12. Diabetes Type II that is managed by insulin.
13. Steroid use in the last 30 days to the exclusions

Where this trial is running

New York, New York

• Rockefeller University — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Joeva Barrow, Ph.D., R.D. — The Rockefeller University and Cornell University
• Study coordinator: Joeva Barrow, Ph.D., R.D.

Conditions Obesity; Metabolic Disease; Cold Exposure