120 Participants Needed

Cold Vest Exposure for Obesity

PC
JB
Overseen ByJoeva Barrow, Ph.D., R.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed medications other than oral contraceptives. Treatments for weight loss or supplements that may alter weight or metabolism are not allowed, but vitamins are okay.

How does the Cold Vest Exposure treatment for obesity differ from other treatments?

Cold Vest Exposure is unique because it uses a wearable vest to expose the body to cold temperatures, which can increase metabolic rate and promote calorie burning, unlike traditional obesity treatments that often focus on diet, exercise, or medication.12345

What is the purpose of this trial?

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.

Research Team

PC

Paul Cohen, Ph.D., M.D.

Principal Investigator

The Rockefeller University

JB

Joeva Barrow, Ph.D., R.D.

Principal Investigator

The Rockefeller University and Cornell University

Eligibility Criteria

This trial is for adults aged 18-35 who are either obese with a BMI over 30 and HgA1c levels below 5.7%, or those with Type II diabetes having higher HgA1c levels but possibly on certain medications. A lean group with BMI between 18.5 and 24.9 and low HgA1c is also included.

Inclusion Criteria

I am obese with Type II diabetes, my BMI is over 30, and my HgA1c is above 6.5% or below if I'm on oral diabetes meds.
I am obese with a BMI over 30 and my blood sugar levels are normal.
My BMI is between 18.5 and 24.9, and my HgA1c is below 5.7%.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Nutritional assessments, BMI, and body composition measurements are conducted

1 week
1 visit (in-person)

Cold Exposure and Rewarming

Participants undergo a 3-hour cold exposure followed by a 3-hour rewarming period to assess metabolome, proteome, and transcriptome changes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the cold exposure and rewarming interventions

4 weeks

Treatment Details

Interventions

  • Cold Vest Exposure Period
  • Fasting
  • Rewarming Exposure Period
Trial Overview The study tests how cold exposure affects the body's ability to generate heat without shivering, which could help treat obesity by activating brown fat thermogenesis—a way our bodies burn calories for warmth.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Obese group with Type II diabetesExperimental Treatment3 Interventions
Body Mass Index (BMI) is \> 30, Hemoglobin A1c (HgA1c) is \>6.5%
Group II: Obese groupExperimental Treatment3 Interventions
Body Mass Index (BMI) is \> 30, Hemoglobin A1c (HgA1c) \<5.7%
Group III: Lean groupExperimental Treatment3 Interventions
Body Mass Index (BMI) is between 18.5 and 24.9. Hemoglobin A1c (HgA1c) \<5.7%

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rockefeller University

Lead Sponsor

Trials
162
Recruited
16,700+

Cornell University

Collaborator

Trials
179
Recruited
14,090,000+

References

Metabolic response to cold air in men and women in relation to total body fat content [2019]
Effectiveness of a light-weight ice-vest for body cooling while wearing fire fighter's protective clothing in the heat. [2022]
Predicting survival time for cold exposure. [2019]
Influence of clothing and body-fat insulation on thermal adjustments to cold-water stress. [2008]
Heat balance at -5 degrees C after cold water immersion. [2016]
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