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Title: Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial
Status: Current
Topic: Cardiovascular Health / Endothelial Function*;Complementary & Alternative Medicine;Diabetes / Insulin Resistance
Funding Source: Fos Biomedical, Inc.
Funding Period: 2021-2022
Study Design: Randomized controlled crossover trial
Purpose:

This study will test the effects of a phototherapy product on certain measures of health in people at risk for type 2 diabetes. According to recent research, certain wavelengths of light appear to activate an enzyme in the mitochondria of cells, which in turn appears to activate signaling pathways in the body.  A recent study of mice with diabetes showed that elevated activity of this enzyme led to reduced blood glucose levels and insulin resistance.

Further Study Details:

This study will compare the effects of 12 weeks each of a phototherapy patch product vs. placebo patches on markers of cardio-metabolic risk and sleep quality.  The product uses 2 small patches worn on the skin that, when activated by body heat, reflect low levels of infrared and visible light to stimulate the skin’s surface.  They don’t contain any drugs or herbal compounds, and don’t put any chemicals in the body. Participants will receive $500 for completing this study. All tests and study products will be provided free of charge.

Eligibility:

Adults who meet the following criteria:

  • are older than 40 years of age (if women, they must be postmenopausal)
  • are non-smokers
  • are overweight
  • have higher-than-normal blood glucose  levels, but not diabetes
  • are willing to do the following over an 8-month period:
    • visit the PRC at Griffin Hospital 5 times for clinical tests
    • wear 2 small patches on their abdomen each day for about 6 months
Evaluation: Outcome measures include markers of cardio-metabolic risk (hemoglobin A1C, insulin sensitivity, serum lipids, C-reactive protein, endothelial function, and body composition) and sleep quality.

Changed at: 12/21/2021 12:41 PM Changed by:
Created at: 12/21/2021 12:41 PM Created by:

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