Clinical trial

Thermogenic Silencer Regulatory Factors in Humans

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06424132

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 35 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Metabolic Disease, Cold Exposure

Full registry 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

Treatments and study arms

Cold Vest Exposure Period

Other

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.

Rewarming Exposure Period

Other

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.

Fasting

Other

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.

Primary outcomes

Identification of adipose tissue transcriptomeBefore and after 3-hour rewarming period.

RNA sequencing to measure and identify a list of gene transcripts that are differentially expressed before and after re-warming. A true change is defined as 1.5 fold increase or decrease in gene expression.

Identification of cold and warm-regulated proteome.Before and after 3 hour cold exposure period and before and after 3 hour rewarming period.

Proteins will be captured from blood and analyzed via mass spectrometry which generates a list of proteins for each sample. The investigators will compare the mean fold change (true change is greater than 1.5 fold) in protein abundance at the specified study time points.

Identification of cold and warm-regulated metabolome.Time frame will be before and after 3 hour cold exposure period as well as before and after 3 hour rewarming period.

Metabolites will be captured from blood and analyzed via mass spectrometry which generates a list of metabolites for each sample. The investigators will compare the mean fold change (true change is greater than 1.5 fold) in metabolite abundance at the specified study time points.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rockefeller University🇺🇸 New York, New York, United States