Metabolism Disorder
Conditions
Brief summary
This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile.
Detailed description
The current research project aims to investigate the effects of large-area fractional laser treatment (LAFLT) on body weight, metabolism, and body composition. Prior research suggests that treating large skin areas with fractional laser therapy may stimulate metabolism and promote weight loss. The MIRIA laser, an FDA-approved fractional laser, is widely used for skin aging, acne scarring, and wrinkle reduction and will be used to evaluate these potential metabolic effects. Subjects aged 18-60 with a BMI of 25-30 will undergo three fractional laser treatments on the abdomen and thighs over 36 weeks, with sessions every four weeks. The study includes six total visits, incorporating photography, non-invasive imaging, x-rays, blood draws, and two optional biopsies.
Interventions
DEVICEFractional Laser
Three fractional laser treatments to the abdomen and thighs at 4 week intervals.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18- 60 years of age; 2. BMI between 25.0 and 30 kg/m2; 3. Subjects must be in good general health, based on answers provided during the screening visit; 4. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol. 5. Females of childbearing potential must be willing and able to use a medically highly effective form of birth control during the entire study.
Exclusion criteria
1. Participation in another investigational drug or device clinical trial in the past 30 days; 2. Currently pregnant or pregnancy within the past 6 months or currently breastfeeding; 3. Have a history of drug or alcohol abuse in the past 3 years or have reported habitual alcohol intake greater than 2 standard drinks per day (e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks); 4. Planning or currently participating in a weight loss program; 5. Plan to change daily diet or level of physical activity; 6. Intake of medication that may affect body weight such as GLP-1 receptor agonists, amitriptyline, bupropion, thyroid medications, etc.; 7. History of cancer which required lymph node biopsy or dissection; 8. Weight loss or gain of 10 kg or more in the past 6 months; 9. History of diabetes mellitus or cardiac disease; 10. Intake of hormone replacement therapy (HRT) in the last 6 months; 11. Infection, surgery, or history of trauma or laser treatment to the treatment area in the past 6 months; 12. Presence of any skin disease on the abdomen or thighs; 13. Have birthmarks, tattoos, scars, or any other disfiguration of the skin in the abdomen or thighs; 14. Presence of sunburn or tan in the abdomen or thighs; 15. Use of any topical application of retinoids in the past 6 weeks on the abdomen or thighs or intake of systemic retinoids in the past 6 months; 16. Use of any prescription topical medication, such as corticosteroids or hydroquinone on the abdomen or thighs in the past 6 weeks; 17. History of keloid formation or hypertrophic scarring; 18. History of bariatric surgery or other major weight-loss procedures; 19. History of abdominal liposuction, abdominoplasty or CoolSculpting; 20. Known allergy to lidocaine or other local anesthetics; 21. The investigator believes that the subject is an unsuitable candidate to participate in the study, receive laser treatment, or would be placed at risk by participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Body Fat (%) | Week 1, 12, 24 | The percent body fat will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA). |
| Body Mass Index (BMI) (kg/m²) | Week 0, 4, 8, 12, 24 | BMI will be calculated using the formula: weight (kg) / \[height (m)\]². Height will be measured at the baseline visit and body weight will be measured at each of the following visits. |
| Waist circumference (cm) | Week 0, 4, 8, 12, 24 | These measurements will be taken at each of the following visits |
| Hip circumference (cm) | Week 0, 4, 8, 12, 24 | These measurements will be taken at each of the following visits |
| Arm circumference (cm) | Week 0, 4, 8, 12, 24 | These measurements will be taken at each of the following visits |
| Total Lean Body Mass (kg) | Week 1, 12, 24 | The total lean body mass will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythrocyte Sedimentation Rate (ESR) | Week 0, 4, 8, 12, 24 | Assessment of the rate at which red blood cells sediment via a blood draw. |
| Histamine | Week 0, 4, 8, 12, 24 | Measurement of plasma histamine levels via a blood draw. |
| Cortisol | Week 0, 4, 8, 12, 24 | Measurement of serum cortisol levels via a blood draw. |
| Oxytocin | Week 0, 4, 8, 12, 24 | Measurement of serum oxytocin levels via a blood draw. |
| Creatine Phosphokinase (CPK) | Week 0, 4, 8, 12, 24 | Measurement of serum CPK via a blood draw. |
| Serum Interleukin-6 (IL-6) | Week 0, 4, 8, 12, 24 | Measurement of interleukin-6 (IL-6) via a blood draw. |
| Serum Norepinephrine | Week 0, 4, 8, 12, 24 | Measurement of norepinephrine via a blood draw. |
| Indirect Calorimetry | Week 0,12, 24 | This is a non-invasive procedure that measures how much energy the body uses. |
| Skin Biopsy (Optional) | Week 1, 12 | 2 optional biopsies will be take pre- and post-laser treatment to measure changes in collagen and skin thickness. |
| Skin Elasticity | Week 0, 4, 8, 12, 24 | Ultrasound will be used to measure skin elasticity. |
| Skin Thickness | Week 0, 4, 8, 12, 24 | Ultrasound will be used to measure skin thickness. |
| VAS Pain Score | Week 1, 4, 8 | The visual analog scale (VAS) pain score will be collected from the subject after each laser treatment. The VAS is a 10cm long scale with 0cm representing "no pain" and 10cm representing "worst possible pain". |
| Hydration Status (%) | Week 0, 12 | Estimation of total body water content as a percentage of body weight using the Bioelectrical impedance analysis (BIA). |
| Total Body Bone Mineral Density (g/cm²) | Week 1, 12, 24 | The total body BMD will be collected from the Dual energy x-ray absorptiometry scan (DEXA). |
| Complete Blood Count (CBC) | Week 0, 4, 8, 12, 24 | Measurement of red blood cell count, white blood cell count, hemoglobin, hematocrit, and platelet count via a blood draw. |
| Comprehensive Metabolic Panel (CMP) | Week 0, 4, 8, 12, 24 | Assessment of glucose, calcium, electrolyte and fluid balance (sodium, potassium, CO2, chloride), kidney function (BUN, creatinine), and liver function (albumin, total protein, ALP, ALT, AST, bilirubin) via a blood draw. |
| Lipid Panel | Week 0, 4, 8, 12, 24 | Measurement of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides via a blood draw. |
| HbA1c | Week 0, 4, 8, 12, 24 | Measurement of hemoglobin A1c via a blood draw. |
| C-Reactive Protein (CRP) | Week 0, 4, 8, 12, 24 | Measurement of CRP levels via a blood draw. |
Countries
United States
Contacts
CONTACTMaria Alora, MD
CONTACTAlicia Van Cott, NP
Outcome results
None listed