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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether carbon dioxide (CO2) can safely reduce subcutaneous body fat. Participants will receive either the CO2 treatment or a sham treatment to compare results. The study seeks individuals who are generally healthy, have a normal body weight, and can maintain their weight without altering diet or exercise during the trial. Those with a history of asthma or skin issues in the treatment area may not be suitable for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new fat reduction methods.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using carbon dioxide (CO2) to reduce fat is generally safe. Studies have found that carboxytherapy, which involves injecting CO2 under the skin, is safe for people who are obese. Most side effects are mild, including bruising and slight to moderate pain. In another study, participants tolerated CO2 treatments well, with no major negative effects reported. This suggests that CO2 could be a safe option for reducing fat deposits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about the CO2 treatment for obesity because it offers a novel approach compared to existing options like lifestyle changes, medications, or bariatric surgery. Unlike these traditional treatments, which often focus on diet alteration, appetite suppression, or surgical intervention, the CO2 treatment utilizes carbon dioxide in an innovative way. This method may target body fat reduction directly by potentially enhancing metabolic processes. If successful, this could provide a less invasive and more efficient alternative for managing obesity.

What evidence suggests that CO2 treatment might be an effective treatment for obesity?

Research has shown that carboxytherapy, a treatment using carbon dioxide (CO2), can help reduce belly size in people who are obese. In this trial, participants will receive either the CO2 treatment or a sham treatment as a comparator. Studies indicate that CO2 might help decrease fat in specific areas and that this treatment is generally safe and well-tolerated by patients. Although more research is needed, these early results are promising for using CO2 to reduce fat and address obesity. ^{1 5 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

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

Subject agrees to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. scirp.org scirp.org/journal/paperinformation?paperid=138180

Safety and Efficacy of Carboxytherapy in Obese Patients Thus, this study aimed to investigate the efficacy and safety of carboxytherapy in reducing abdominal circumference in patients hospitalized for obesity ...

2. withpower.com withpower.com/trial/co2-treatment-for-obesity-5e80c

CO2 Treatment for Obesity · Info for Participants Long-term studies show that bariatric surgery significantly improves or eliminates obesity-related health issues and enhances quality of life, with a low ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10703502/

Fractional Carbon Dioxide Laser versus Trichloroacetic ... Both fractional CO₂ laser and TCA (20%) appear effective, well-tolerated, and promising treatment options for AN. TCA is a simple, effective method with faster ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0306456522000651

Whole-body cryostimulation in obesity. A scoping review The cryogenic stimulus has important anti-inflammatory/antioxidant effects and its effectiveness is directly related to the individual percentage of fat mass ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10638870/

CO2 laser therapy for management of stress urinary ... CO2 laser therapy significantly decreased the 1-h pad weights at 3 months [n = 5 studies, MD = −3.656 g, 95% CI (−5.198, −2.113), p < 0.001], 6 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211517301483

Safety and long-term efficacy of fractional CO2 laser ... CO2-Laser application showed a beneficial safety profile and no major adverse events were reported. Vaginal laser treatment resulted in both a statistically ...

7. scirp.org scirp.org/pdf/jcdsa2024144_41050739.pdf

Safety and Efficacy of Carboxytherapy in Obese Patients The intervention was effective for reducing localized fat deposits, with min- imal side effects (ecchymosis and mild to moderate pain).

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31306275/

Safety of Subcutaneous Infiltration of Carbon Dioxide ... Safety of Subcutaneous Infiltration of Carbon Dioxide (Carboxytherapy) for Abdominal Fat Reduction: A Pilot Study.