Laser Therapy for Metabolic Disorders

(MELT Trial)

Overseen By Alicia Van Cott, NP

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: GLP-1 agonists, Antidepressants, Thyroid meds, HRT

Disqualifiers: Pregnancy, Alcohol abuse, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 6

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special type of laser treatment affects the metabolic health of adults. The focus is on using large-area fractional laser treatments on the abdomen and thighs to determine if it can improve metabolic profiles, such as weight and body composition. Individuals who are slightly overweight (BMI between 25 and 30), in generally good health, and without recent major weight changes may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance metabolic health.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that may affect body weight, such as GLP-1 receptor agonists, amitriptyline, bupropion, thyroid medications, or hormone replacement therapy. If you are on these medications, you may need to stop them to participate.

What prior data suggests that this laser therapy is safe for metabolic disorders?

Research has shown that fractional laser treatments have been tested for safety in various situations. For example, one study examined the use of lasers to aid wound healing on the lower legs, aiming to assess the treatment's effectiveness and safety over 12 weeks.

While lasers offer potential benefits, some known risks include bleeding, pain, and infection after treatment. However, specific information on the frequency of these risks with fractional laser treatments remains limited.

In mice, laser treatments significantly increased energy use over several days, but this finding does not directly apply to humans. Laser therapies are used in other medical areas, suggesting a degree of safety. However, the exact safety details for treating metabolic disorders are still under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fractional Laser treatment for metabolic disorders because it uses a unique approach by employing large area fractional laser technology, specifically with the MIRIA laser, targeting the abdomen and thighs. Unlike traditional treatments that might rely on medication or invasive procedures, this laser therapy offers a non-invasive option that potentially enhances metabolic function through precise energy delivery to targeted areas. This method could lead to improved outcomes with fewer side effects and a faster recovery time compared to conventional treatments.

What evidence suggests that this laser therapy is effective for metabolic disorders?

Studies have shown that fractional laser treatments can significantly affect the body's metabolism. In one study on mice, targeted laser treatment increased energy use by up to 91% over six days, indicating a boost in metabolic activity. Other research has found that laser treatment can change how the body processes fats. Additionally, fractional lasers increase collagen production, which may improve skin health and appearance. This trial will investigate the effects of fractional laser treatment on metabolic disorders in humans. These findings suggest that fractional lasers might help improve metabolism in humans, but more research is needed to confirm these effects. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults aged 18-60 with a BMI of 25.0 to 30 kg/m2 in good health can join this study on laser therapy for metabolism. They must not be pregnant, breastfeeding, or have had significant weight changes recently and should agree to use effective birth control.

Inclusion Criteria

BMI between 25.0 and 30 kg/m2

Subjects must be in good general health, based on answers provided during the screening visit

Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol

Exclusion Criteria

Participation in another investigational drug or device clinical trial in the past 30 days

Currently pregnant or pregnancy within the past 6 months or currently breastfeeding

History of drug or alcohol abuse in the past 3 years or habitual alcohol intake greater than 2 standard drinks per day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three fractional laser treatments on the abdomen and thighs over 36 weeks, with sessions every four weeks

36 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fractional Laser

Trial Overview The trial is testing the effects of large area fractional laser treatment (LAFLT) on metabolic profiles in adults. It's an open-label pilot study at a single center where participants will receive LAFLT to see how it affects their metabolism.

How Is the Trial Designed?

Group I: Fractional Laser treatment Experimental Treatment 1 Intervention

Large Area Fractional Laser treatments to the abdomen and thighs using the MIRIA laser.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10783634/

Large area fractional laser treatment of mouse skin increases ... Localized laser skin treatment resulted in systemic metabolic effects in mice. Treated mice increased energy expenditure up to 91% over a 6-day period.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9971340/

Association of Early Clinical Response to Laser ... Discrepant responses to non-ablative fractional laser were associated with differences in lipid metabolism and keratinization ... Acute effects of ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lsm.23850?af=R

Expert Consensus on Clinical Recommendations for ... Fractional CO2 laser is a popular and effective skin rejuvenation treatment with minimal downtime and side effects. This study presents new ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.1010878/full

1540-nm fractional laser treatment modulates proliferation ... Indeed, our results revealed a significant increase in type III collagen expression improvement, confirming the laser-induced neocollagenesis effect.

5. link.springer.com link.springer.com/article/10.1007/s10103-021-03329-7

Efficacy of fractional laser, radiofrequency and IPL ... The effectiveness of the therapy was found to be 2, 3 or 4 degree, respectively [15]. The same scale of patients and investigators assessment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7008747/

Evaluation of Laser Effects on the Human Body After ... Laser therapy like the other methods has advantages and disadvantages. Some risks such as bleeding, pain, and infection are created after laser therapy.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03644849

Evaluating the Safety and Efficacy of Fractionated Carbon ... This study will evaluate the efficacy and safety of laser therapy on postoperative lower extremity wound healing over 12 weeks.

8. jaad.org jaad.org/article/S0190-9622(24)02263-1/fulltext

49921 Safety of Ablative Fractional Laser-Assisted Drug ... Potential advantages of LADD procedures include a reduction in the topical drug concentration and a reduction in the duration of topical treatment needed for ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1572100024000188

Efficacy and safety of fractional carbon dioxide laser ... Fractional CO 2 laser followed by 5-ALA PDT is a promising method for treating keloids. However, its synergetic effects need to be validated through clinical ...