Metabolism Enhancement by Laser Therapy
ConditionMetabolism Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMassachusetts General Hospital
About this trial
This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18- 60 years of age;
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.
Disqualifiers
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;
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);
Planning or currently participating in a weight loss program;
Trial design
Design model
Single group
Treatments tested in this trial
Fractional Laser
DeviceThree fractional laser treatments to the abdomen and thighs at 4 week intervals.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Fractional Laser treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent Body Fat (%)
The percent body fat will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).
Time frame
Week 1, 12, 242
Body Mass Index (BMI) (kg/m²)
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.
Time frame
Week 0, 4, 8, 12, 243
Waist circumference (cm)
These measurements will be taken at each of the following visits
Time frame
Week 0, 4, 8, 12, 244
Hip circumference (cm)
These measurements will be taken at each of the following visits
Time frame
Week 0, 4, 8, 12, 24Secondary outcomes
1
Complete Blood Count (CBC)
Measurement of red blood cell count, white blood cell count, hemoglobin, hematocrit, and platelet count via a blood draw.
Time frame
Week 0, 4, 8, 12, 242
Comprehensive Metabolic Panel (CMP)
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.
Time frame
Week 0, 4, 8, 12, 243
Lipid Panel
Measurement of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides via a blood draw.
Time frame
Week 0, 4, 8, 12, 244
HbA1c
Measurement of hemoglobin A1c via a blood draw.
Time frame
Week 0, 4, 8, 12, 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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