Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05628597
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-10-14
Brief Title:
Effects of Fos Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes
Sponsor:
Griffin Hospital
Organization:
Griffin Hospital
Study Overview
Official 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:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose Phototherapy has an array of potential benefits in human health The effects of a non-transdermal Fos Biomedical product which utilizes the concept of phototherapy on diabetes risk factors and sleep quality in people at risk for type 2 diabetes are unclear Proposed is a single-blind randomized crossover placebo-controlled trial to assess the impact of daily use of the Fos Biomedical product for a 12-week period on cardio-metabolic risk factors and self-reported sleep quality among adults at risk for type 2 diabetes
Specific Aims
To determine the effects of the use of the Fos Biomedical product daily for 12 weeks as compared to placebo patch on glycemic control in adults at risk for type 2 diabetes Specifically to show that the use of the Fos Biomedical product for 12 weeks as compared to placebo patch will improve glycated hemoglobin in adults at risk for type 2 diabetes
To assess the effects of the use of the Fos Biomedical product versus placebo patch for a 12-week period on insulin sensitivity serum lipids C-reactive protein anthropometric measures self-reported sleep quality and endothelial function in adults at risk for type 2 diabetes Specifically to show clinically meaningful improvement or neutral effects in insulin sensitivity serum lipids C-reactive protein anthropometric measures self-reported sleep quality and endothelial function in adults at risk for type 2 diabetes
To assess the impact of Fos Biomedical product on liver function and kidney function in adults at risk for type 2 diabetes
Hypotheses
Daily use of the Fos Biomedical product for 12 weeks will improve glycated hemoglobin in adults at risk for type 2 diabetes
Daily use of the Fos Biomedical product for 12 weeks will improve or have neutral effects on insulin sensitivity serum lipids C-reactive protein anthropometric measures self-reported sleep quality and endothelial function in adults at risk for type 2 diabetes
The use of the Fos Biomedical product will have no clinically meaningful adverse effects on liver function and kidney function in adults at risk for type 2 diabetes
Specific Aims
To determine the effects of the use of the Fos Biomedical product daily for 12 weeks as compared to placebo patch on glycemic control in adults at risk for type 2 diabetes Specifically to show that the use of the Fos Biomedical product for 12 weeks as compared to placebo patch will improve glycated hemoglobin in adults at risk for type 2 diabetes
To assess the effects of the use of the Fos Biomedical product versus placebo patch for a 12-week period on insulin sensitivity serum lipids C-reactive protein anthropometric measures self-reported sleep quality and endothelial function in adults at risk for type 2 diabetes Specifically to show clinically meaningful improvement or neutral effects in insulin sensitivity serum lipids C-reactive protein anthropometric measures self-reported sleep quality and endothelial function in adults at risk for type 2 diabetes
To assess the impact of Fos Biomedical product on liver function and kidney function in adults at risk for type 2 diabetes
Hypotheses
Daily use of the Fos Biomedical product for 12 weeks will improve glycated hemoglobin in adults at risk for type 2 diabetes
Daily use of the Fos Biomedical product for 12 weeks will improve or have neutral effects on insulin sensitivity serum lipids C-reactive protein anthropometric measures self-reported sleep quality and endothelial function in adults at risk for type 2 diabetes
The use of the Fos Biomedical product will have no clinically meaningful adverse effects on liver function and kidney function in adults at risk for type 2 diabetes
Detailed Description:
Background Pre-diabetes is a serious medical condition associated with elevated blood glucose that is higher than normal but not high enough to be considered for a diagnosis of diabetes An estimated 88 million adults aged 18 years and older have pre-diabetes in the United States US yet more than 84 of those with pre-diabetes are unaware Those with pre-diabetes are at increased risk for developing diabetes cardiovascular disease CVD and stroke Fifteen to 30 of individuals with pre-diabetes are likely to develop type 2 diabetes mellitus T2DM within 5 years Pre-diabetes is a major risk factor associated with metabolic syndrome Insulin resistance and excess body weight are common in both pre-diabetes and metabolic syndrome
Metabolic syndrome - a cluster of risk factors that increase the risk of T2DM and CVD - affects about 35 of adults in the US The risk factors for metabolic syndrome include hypertension dyslipidemia hyperglycemia and excess body weight especially due to excess central body fat These risk factors represent an independent risk for developing T2DM CVD and stroke as well as an increased risk of mortality The risk of T2DM CVD and stroke increases with the number of metabolic risk factors Persons with metabolic syndrome when compared with healthy persons have a 5-fold increased risk for T2DM The combination of pre-diabetes and metabolic syndrome compared with healthy persons is associated with an even higher ie 21-fold risk for T2DM
An inconsistent sleep schedule or a general lack of sleep has been associated with increased risk of developing T2DM Specifically sleep disturbance is associated with pre-diabetes and metabolic syndrome Sleep disturbance is associated with poor cardio-metabolic control ie hypertension dyslipidemia and a reduction in insulin level released after eating Further elevated stress hormones that keep the body awake have been associated with increased blood glucose level by increasing the production of glucose in the liver decreasing glucose uptake in the muscles and fat cells decreasing insulin secretion and increasing insulin resistance In addition sleep deprivation has also been associated with increased appetite which heightens the risk of T2DM Again insufficient sleep has been associated with higher levels of ghrelin which increase appetite and lower levels of leptin which signals fullness Therefore improving sleep patterns has the potential to improve cardio-metabolic risk factors among those at risk for T2DM
Lifestyle practices that promote good sleep hygiene and reduce stress have been associated with lower risk of T2DM and the control of cardio-metabolic risk factors among those at risk for T2DM In addition consistent sleep patterns have also been associated with improved glycemic control in T2DM Phototherapy is thought to help improve sleep patterns in persons with circadian rhythm sleep disorders to normal sleeping patterns and times Further in a meta-analysis phototherapy therapy was shown to improve symptoms of vascular complications and quality of life that are linked to diabetes In animal models phototherapy has been shown to reduce abdominal fat In addition phototherapy has also been associated with improved insulin sensitivity in T2DM
Phototherapy also known as photobiomodulation PBM or low-level light therapy has been known for almost 50 years but still has not gained widespread acceptance largely due to uncertainty about the mechanisms of action In recent years much knowledge has been gained in this area The primary site of light absorption in mammalian cells has been identified as the mitochondria and more specifically cytochrome c oxidase CCO an enzyme that contains both heme and copper centers and is known to reduce oxygen to water at the end of the mitochondrial respiratory chain CCO has recently been shown to have an additional enzymatic activity the reduction of nitrite to nitric oxide NO upon exposure to low-intensity light The absorption peaks of CCO are in the visible 420-450 nm and 600-700 nm and the near-infrared 760-980 nm spectral region
The leading hypothesis is that photons dissociate inhibitory NO from CCO leading to an increase in electron transport mitochondrial membrane potential and ATP production Another hypothesis concerns light-sensitive ion channels that can be activated allowing calcium to enter the cell After the initial photon absorption events numerous signaling pathways are activated via reactive oxygen species ROS cyclic AMP NO and Ca2 leading to activation of transcription factors These transcription factors can lead to increased expression of genes related to protein synthesis cell migration and proliferation anti-inflammatory signaling anti-apoptotic proteins and antioxidant enzymes
In a recent study showing that PBM reduced blood glucose and insulin resistance and reversed metabolic abnormalities in skeletal muscle in two diabetic mouse models PBMT accelerated adenosine triphosphate ATP and ROS generation by elevating CCO activity ROS-induced activation of phosphatase and tensin homolog PTEN protein kinase B AKT signaling after PBMT promoted glucose transporter GLUT4 translocation and glycogen synthase activation accelerating glucose uptake and glycogen synthesis in skeletal muscle
The effects of the non-transdermal Fos Biomedical patch system which utilizes the concept of phototherapy on cardio-metabolic risk factors and sleep quality in persons at risk for T2DM are unclear Proposed is a randomized crossover placebo-controlled trial to assess the impact of the Fos Biomedical patch system use on cardio-metabolic risk factors and sleep quality among adults at risk for type 2 diabetes Specifically the investigators hypothesize that the use of the Fos Biomedical patch system for 12 weeks as compared to placebo patch system will improve glycated hemoglobin other markers of cardio-metabolic risk factors and sleep quality in adults at risk for T2DM
Metabolic syndrome - a cluster of risk factors that increase the risk of T2DM and CVD - affects about 35 of adults in the US The risk factors for metabolic syndrome include hypertension dyslipidemia hyperglycemia and excess body weight especially due to excess central body fat These risk factors represent an independent risk for developing T2DM CVD and stroke as well as an increased risk of mortality The risk of T2DM CVD and stroke increases with the number of metabolic risk factors Persons with metabolic syndrome when compared with healthy persons have a 5-fold increased risk for T2DM The combination of pre-diabetes and metabolic syndrome compared with healthy persons is associated with an even higher ie 21-fold risk for T2DM
An inconsistent sleep schedule or a general lack of sleep has been associated with increased risk of developing T2DM Specifically sleep disturbance is associated with pre-diabetes and metabolic syndrome Sleep disturbance is associated with poor cardio-metabolic control ie hypertension dyslipidemia and a reduction in insulin level released after eating Further elevated stress hormones that keep the body awake have been associated with increased blood glucose level by increasing the production of glucose in the liver decreasing glucose uptake in the muscles and fat cells decreasing insulin secretion and increasing insulin resistance In addition sleep deprivation has also been associated with increased appetite which heightens the risk of T2DM Again insufficient sleep has been associated with higher levels of ghrelin which increase appetite and lower levels of leptin which signals fullness Therefore improving sleep patterns has the potential to improve cardio-metabolic risk factors among those at risk for T2DM
Lifestyle practices that promote good sleep hygiene and reduce stress have been associated with lower risk of T2DM and the control of cardio-metabolic risk factors among those at risk for T2DM In addition consistent sleep patterns have also been associated with improved glycemic control in T2DM Phototherapy is thought to help improve sleep patterns in persons with circadian rhythm sleep disorders to normal sleeping patterns and times Further in a meta-analysis phototherapy therapy was shown to improve symptoms of vascular complications and quality of life that are linked to diabetes In animal models phototherapy has been shown to reduce abdominal fat In addition phototherapy has also been associated with improved insulin sensitivity in T2DM
Phototherapy also known as photobiomodulation PBM or low-level light therapy has been known for almost 50 years but still has not gained widespread acceptance largely due to uncertainty about the mechanisms of action In recent years much knowledge has been gained in this area The primary site of light absorption in mammalian cells has been identified as the mitochondria and more specifically cytochrome c oxidase CCO an enzyme that contains both heme and copper centers and is known to reduce oxygen to water at the end of the mitochondrial respiratory chain CCO has recently been shown to have an additional enzymatic activity the reduction of nitrite to nitric oxide NO upon exposure to low-intensity light The absorption peaks of CCO are in the visible 420-450 nm and 600-700 nm and the near-infrared 760-980 nm spectral region
The leading hypothesis is that photons dissociate inhibitory NO from CCO leading to an increase in electron transport mitochondrial membrane potential and ATP production Another hypothesis concerns light-sensitive ion channels that can be activated allowing calcium to enter the cell After the initial photon absorption events numerous signaling pathways are activated via reactive oxygen species ROS cyclic AMP NO and Ca2 leading to activation of transcription factors These transcription factors can lead to increased expression of genes related to protein synthesis cell migration and proliferation anti-inflammatory signaling anti-apoptotic proteins and antioxidant enzymes
In a recent study showing that PBM reduced blood glucose and insulin resistance and reversed metabolic abnormalities in skeletal muscle in two diabetic mouse models PBMT accelerated adenosine triphosphate ATP and ROS generation by elevating CCO activity ROS-induced activation of phosphatase and tensin homolog PTEN protein kinase B AKT signaling after PBMT promoted glucose transporter GLUT4 translocation and glycogen synthase activation accelerating glucose uptake and glycogen synthesis in skeletal muscle
The effects of the non-transdermal Fos Biomedical patch system which utilizes the concept of phototherapy on cardio-metabolic risk factors and sleep quality in persons at risk for T2DM are unclear Proposed is a randomized crossover placebo-controlled trial to assess the impact of the Fos Biomedical patch system use on cardio-metabolic risk factors and sleep quality among adults at risk for type 2 diabetes Specifically the investigators hypothesize that the use of the Fos Biomedical patch system for 12 weeks as compared to placebo patch system will improve glycated hemoglobin other markers of cardio-metabolic risk factors and sleep quality in adults at risk for T2DM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None