Effects of a Red/Gold/IR LED Combination Light on Reduction of Fat

Study Overview
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Brief Summary
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An open-label evaluation of the effects of a red/gold/IR LED combination light on reduction of fat. The results shall be compared to previous results from a comparator device utilizing only red LED monotherapy for the non-invasive reduction in fat layer for body contouring.

Detailed Description
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The combination of gold/red/IR light is theorized to enhance the effect of the deeper penetrating red/IR light with the photomodulated effects of gold light. The light is positioned alongside the patient as they lay, or sit on a treatment table. A light panel is mounted to an articulating arm for positioning the light at the correct treatment position above the patient (non-contact). The effects of a red/gold/IR combination LED light therapy device on circumferential reduction of fat will be measured, and the overall health of the patients will be monitored using blood tests.

Official Title
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Effects of a Red/Gold/IR LED Combination Light on Reduction of Fat

Conditions
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Body Image, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: LLLT Combination Red/Gold/IR Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study participant is 18 years of age or older. Diagnosed with adult-onset (type 2) diabetes. Obesity Exclusion Criteria: Photosensitive condition or medication. Active chemotherapy treatment or other cancer treatment. Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation. Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements. Chronic stomach conditions (IBS, Crohn's, Ulcerative Colitis, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LLLT Combination Red/Gold/IR Therapy|Three LLLT combination treatments per week over the course of two consecutive weeks, and a final follow up on day-15 (total of 7 treatments).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Reduction | Circumferential reduction of fat as measured around the observation areas of the body. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Health Improvement | The secondary outcome of this study is to monitor patient health changes during the treatment period. The principal method for monitoring patient health is through blood testing. There is some evidence in literature that patients undergoing fat reduction benefit from secondary effects associated with their general health. | 15 days |