Clinical trial NCT04525573: Effects of a Red/Gold/IR LED Combination Light on Reduction of Fat
Official title: Effects of a Red/Gold/IR LED Combination Light on Reduction of Fat
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Body Image
Diabetes Mellitus, Type 2
Lead sponsor: Ward Photonics LLC
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women over the age of 18 and with diagnosed Type 2 diabetes who are seeking fat loss.

Brief summary: 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: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Fat Reduction
timeFrame: 15 days
Secondary outcomes:
measure: General Health Improvement
timeFrame: 15 days
Other outcomes:
Locations:
city: Schaumburg
country: United States
facility: Horizon Medical Center
state: Illinois
Study officials:
affiliation: Horizon Medical Center
name: Ahsaraf Dabawala, MD
role: PRINCIPAL_INVESTIGATOR
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