Thermogenic Silencer Regulatory Factors in Humans

Plain-language summary

This study examines thermogenic (heat-producing) regulatory factors in the body during cold exposure, rewarming and fasting periods. It is enrolling lean, obese, and obese type 2 diabetic participants aged 18-35. It is being run as a study with no assigned phase; it is not currently recruiting but is ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Active, not recruiting

Sponsor

Rockefeller University

Intervention

Cold Vest Exposure Period, Rewarming Exposure Period, Fasting

Start date

8/16/2024

Estimated completion

12/4/2026

Countries

United States

Related genes

Locations

• New York, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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