CO2 Treatment for Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Diet pills

Disqualifiers: Pregnancy, Asthma, COPD, Skin infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not start any new treatments for body contouring or weight loss during the study.

How does CO2 treatment for obesity differ from other treatments?

CO2 treatment for obesity is unique because it likely involves a novel mechanism or administration method not covered by traditional diet, exercise, or pharmacological approaches, which focus on lifestyle changes, appetite control, or surgical interventions. ^{1 2 3 4 5}

What is the purpose of this trial?

The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for men and women aged 18 or older with a BMI between 18.5-24.99, who are in good health and willing to avoid other body contouring treatments or significant lifestyle changes during the study. It's not for pregnant individuals, those unable to consent, people with certain diseases like asthma or skin infections near the treatment area, bleeding disorders, lidocaine allergies, or any condition that could affect their participation.

Inclusion Criteria

Your body mass index, which is a measure of your weight in relation to your height, falls within the range of 18.5 to 24.99.

Subject agrees to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study

I agree not to pursue any other body contouring or weight loss treatments during the study.

Exclusion Criteria

I have had or will have procedures that might affect my treatment area.

I have a history of asthma or COPD.

I have a bleeding disorder or a condition affecting blood clotting.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CO2 treatment or sham treatment for fat reduction

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CO2
• Sham

Trial Overview The study is testing the effectiveness and safety of carbon dioxide (CO2) treatments for reducing subcutaneous fat compared to a sham procedure (a fake treatment used as a control). Participants will be randomly assigned to receive either CO2 treatments or sham procedures.

Participant Groups

Group I: treatment Experimental Treatment 1 Intervention

CO2 treatment

Group II: sham Placebo Group 1 Intervention

sham treatment

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Bariatric surgery is a safe and effective treatment for class II and III obesity, with experienced surgeons achieving weight reductions of about 50% with restrictive procedures and up to 75% with combined methods.

Long-term studies show that bariatric surgery significantly improves or eliminates obesity-related health issues and enhances quality of life, with a low perioperative mortality rate of 0.2-1.0% and a maximum morbidity rate of 20%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical procedures for severely obese patients: impact and long-term results]. Potoczna, N., Steffen, R., Horber, FF.[2019]

References

1. France pubmed.ncbi.nlm.nih.gov

[Current ideas on the treatment of obesity]. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Surgical procedures for severely obese patients: impact and long-term results]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Medical therapy for obesity. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Seeking satiety: From signals to solutions. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Obesity and pharmacologic therapy. [2019]