Thermogenic Silencer Regulatory Factors in Humans
Identification of Thermogenic Silencing Regulatory Factors as Biomarkers of Metabolic Health in Humans
Rockefeller University
120 participants
Aug 16, 2024
INTERVENTIONAL
Conditions
Summary
A promising approach to correct the metabolic dysfunction associated with obesity is to activate brown fat non-shivering thermogenesis (NST). A critical limitation with NST as a therapeutic option, however, is that this beneficial process is silenced under human physiological temperature conditions and the mechanisms of how this occurs is unknown. This study will be the first to identify human NST silencing factors that may be targeted for the treatment of obesity and metabolic disorders.
Eligibility
Inclusion Criteria4
- Age between 18 years old and 35
- Lean group: BMI is between 18.5 and 24.9. HgA1c \<5.7%
- Obese group: BMI is \>30, HgA1c \<5.7%
- 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 Criteria13
- Diabetes type I (self-report)
- Diagnosis of thyroid disease (including goiter, hyperthyroidism, hypothyroidism, thyroiditis)(self-report)
- Diagnosis with cancer including skin cancer (self-report)
- Diagnosis or evidence of Raynaud's Syndrome or systemic sclerosis (self-report)
- A recent diagnosis of Coronavirus Disease 2019 (COVID-19) (last 2 weeks) or hospitalized at the time of diagnosis with COVID-19
- Any vaccine administration within two weeks preceding the study procedure
- Currently pregnant
- 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.
- Has consumed nicotine (smoking, inhaling, ingesting) within the last 6 months
- Has used illicit drugs within the last 6 months (marijuana users are eligible unless consumed in the last 30 days).
- 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
- Diabetes Type II that is managed by insulin.
- Steroid use in the last 30 days to the exclusions
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Interventions
A cold vest will be placed on the participant which consists of a water-perfused wearable vest, size S-M or M-L with adjustable straps attached to a small 'cooler' reservoir to circulate cold water between the vest and the cooler (Polar Products, Stow, OH- Product link: www.polarproducts.com/polarshop/pc/CoolOR-13-Quart-System-with-Arctic-Chiller-p24757.htm) This product is safe and recommended by experimental guidelines for human BAT studies. Participants will be cold exposed for a period of 3 hours resting in a reclined position engaged in reading and/or digital entertainment of their choice.
Following cold exposure, the cold vests will be removed, and participants will be offered a warm blanket to ease the transition from cold back to warm temperatures. Participants will then be moved to an adjacent warm room maintained at 30 degrees celsius and asked to return to the resting position of their choice. Participants will then engage in reading and/or digital entertainment for a 3-hour warm exposure period.
Participants will be requested to refrain from food and caloric drinks for 12 hours (starting at 8pm) prior to the study visit. Blood will then be drawn the following morning (between 8 and 9am) 30mins later following a breakfast meal (9:30am- 10am). Participants will be housed in a room with ambient temperature at 25 degrees celsius between the two blood draws.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06424132