Cardio-metabolic health and sleep quality in adults at risk for Type 2 Diabetes using the Fos Biomedical Non-Transdermal Patch System via photo-biomodulation: A randomized, placebo-controlled crossover trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2025-02-15 DOI:10.1016/j.conctc.2025.101448

Valentine Y. Njike , Rockiy G. Ayettey , Judith A. Treu , Beth Patton Comerford , Maureen Onuigbo

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引用次数: 0

Abstract

Background

The impact of the Fos Biomedical non-transdermal patch system (NTPS) that stimulates the skin with low light levels to generate photo-biomodulation (PBM) effects on cardio-metabolic health and sleep quality is unclear. We examined the impact of FBPS compared with placebo on cardio-metabolic risk and sleep quality in persons at risk for type 2 diabetes mellitus (T2DM).

Methods

The study was a randomized, controlled, double-blind, crossover trial of 39 adults (mean age 64.4 years; 28 women, 11 men; 38 Caucasians, 1 African American) at risk for T2DM assigned to one of two possible sequence permutations of two treatments (Fos Biomedical NTPS and placebo), with an 8-week washout period. Fos Biomedical NTPSs are designed to stimulate the skin with low light levels to produce PBM effects. Participants were instructed to apply the active or placebo patches above and below the belly button for 12 h each day for 12 weeks. Primary outcome measure was glycated hemoglobin (HbA1c). Secondary outcome measures included insulin sensitivity, lipid profile, blood pressure, body composition, C-reactive protein, endothelial function, and sleep quality.

Results

Compared with the placebo, the Fos Biomedical NTPS did not improve glycemic control: HbA1c (0.1 ± 0.2 % vs. 0.1 ± 0.2 %; p = 0.5154). Compared with placebo, Fos Biomedical NTPS reduced endothelial function (−1.7 ± 12.1 % vs. 3.9 ± 10.0 %; p = 0.0344) while other markers of cardiovascular risk (i.e., body composition, blood pressure, lipid profile, and inflammatory biomarker) and sleep quality were unaffected (p > 0.05).

Conclusions

Photo-biomodulation generated from Fos Biomedical NTPS did not improve biomarkers of cardio-metabolic risk and sleep quality among those at risk for T2DM.

Clinical trial registration number

NCT05628597.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.