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
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-metabo...
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| Language: | English |
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Elsevier
2025-04-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000225 |
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| author | Valentine Y. Njike Rockiy G. Ayettey Judith A. Treu Beth Patton Comerford Maureen Onuigbo |
| author_facet | Valentine Y. Njike Rockiy G. Ayettey Judith A. Treu Beth Patton Comerford Maureen Onuigbo |
| author_sort | Valentine Y. Njike |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-35c86ef02f4d4250be26998e7e8a3b3f |
| institution | OA Journals |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-35c86ef02f4d4250be26998e7e8a3b3f2025-08-20T01:49:30ZengElsevierContemporary Clinical Trials Communications2451-86542025-04-014410144810.1016/j.conctc.2025.101448Cardio-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 trialValentine Y. Njike0Rockiy G. Ayettey1Judith A. Treu2Beth Patton Comerford3Maureen Onuigbo4Yale-Griffin Prevention Research Center, USA; Corresponding author.Yale-Griffin Prevention Research Center, 130 Division Street, Derby, CT 06418, USAYale-Griffin Prevention Research Center, 130 Division Street, Derby, CT 06418, USAYale-Griffin Prevention Research Center, 130 Division Street, Derby, CT 06418, USAGriffin Hospital, 130 Division Street, Derby, CT 06418, USABackground: 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.http://www.sciencedirect.com/science/article/pii/S2451865425000225Pre-diabetesMetabolic syndromeType 2 diabetesPhototherapyPhoto-biomodulationFos Biomedical patch |
| spellingShingle | Valentine Y. Njike Rockiy G. Ayettey Judith A. Treu Beth Patton Comerford Maureen Onuigbo 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 Contemporary Clinical Trials Communications Pre-diabetes Metabolic syndrome Type 2 diabetes Phototherapy Photo-biomodulation Fos Biomedical patch |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Pre-diabetes Metabolic syndrome Type 2 diabetes Phototherapy Photo-biomodulation Fos Biomedical patch |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000225 |
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