Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550115
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Impact of Circulating and Tissue-specific Lipids on Vascular Function and Insulin Sensitivity in Chronic Night Shift Workers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Circulating and Tissue-specific Lipids on Vascular Function and Insulin Sensitivity in Chronic Night Shift Workers
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHINE
Brief Summary:
People who experience repeated bouts of circadian misalignment such as shift workers are at higher risk of cardiovascular disease CVD and Type 2 diabetes T2D compared to daytime workers However the mechanisms by which shift work and associated circadian misalignment increase CVD and T2D risk are unknown This project will examine whether elevated plasma lipids are a mechanism by which circadian misalignment impairs vascular function insulin sensitivity glucose homeostasis and muscle lipid accumulation which could be targeted to prevent and treat cardiometabolic disease in people who chronically experience circadian misalignment which includes more than 20 of the US workforce
Detailed Description:
There is growing recognition that timing of behaviors such as eating sleeping and activity have a significant impact on human health and disease risk For example when people are awake at the wrong time of the day ie during the biological night a mismatch occurs between behavior and biology termed circadian misalignment Shift workers experience repeated bouts of circadian misalignment and are at higher risk of cardiovascular disease CVD and Type 2 diabetes T2D compared to people who work days However the mechanisms by which shift work and associated circadian misalignment increase CVD and T2D risk are unknown
Data from the investigators and others demonstrate impaired vascular endothelial function and insulin sensitivity during circadian misalignment two important risk factors for future development of CVD and T2D Furthermore the investigators published and unpublished data support that circadian misalignment increases circulating bioactive lipids known to associate with impaired endothelial function and insulin resistance Indeed shift workers also have elevated circulating lipids though it is not known which specific lipids are elevated and whether they are associated with impaired vascular function andor insulin sensitivity Using a circadian-based eating intervention time-restricted eating TRE we can consistently reduce lipids in circulation as well as reduce heart rate and blood pressure and improve glucose homeostasis
Therefore the overall objective for this project is to examine whether increased plasma lipids are a potential mechanism by which chronic circadian misalignment impairs cardiovascular and metabolic health with the long-term goal of identifying novel therapeutic targets to combat the risks for disease when circadian misalignment is unavoidable The central hypothesis is that reducing plasma lipids in night shift workers via TRE will improve vascular function insulin sensitivity and glucose homeostasis and reduce muscle tissue lipid accumulation To test the hypothesis we will conduct a 12-week randomized crossover study in 50 non-rotating night shift workers 25Females25Males 18-65years with existing cardiometabolic risk factors At the end of each 4-week outpatient condition TRE vs Control with an intervening 4-week washout period we will conduct rigorous 3-day inpatient assessment to determine the impact of plasma lipid reduction via TRE in chronic night shift workers on 1 vascular function and blood pressure and 2 whole body and muscle-specific insulin sensitivity glucose homeostasis and muscle lipid accumulation
Achievement of these aims will identify a potential mechanism by which circadian misalignment impairs vascular function and insulin sensitivity elevated plasma lipids as well as a non-pharmacological tool TRE that could be implemented to reduce cardiometabolic disease risk in populations at elevated risk in 20 of the US workforce who work nonstandard hours including military personnel police paramedics firefighters pilots medical doctors and nurses as well as people with sleep and circadian disorders
Data from the investigators and others demonstrate impaired vascular endothelial function and insulin sensitivity during circadian misalignment two important risk factors for future development of CVD and T2D Furthermore the investigators published and unpublished data support that circadian misalignment increases circulating bioactive lipids known to associate with impaired endothelial function and insulin resistance Indeed shift workers also have elevated circulating lipids though it is not known which specific lipids are elevated and whether they are associated with impaired vascular function andor insulin sensitivity Using a circadian-based eating intervention time-restricted eating TRE we can consistently reduce lipids in circulation as well as reduce heart rate and blood pressure and improve glucose homeostasis
Therefore the overall objective for this project is to examine whether increased plasma lipids are a potential mechanism by which chronic circadian misalignment impairs cardiovascular and metabolic health with the long-term goal of identifying novel therapeutic targets to combat the risks for disease when circadian misalignment is unavoidable The central hypothesis is that reducing plasma lipids in night shift workers via TRE will improve vascular function insulin sensitivity and glucose homeostasis and reduce muscle tissue lipid accumulation To test the hypothesis we will conduct a 12-week randomized crossover study in 50 non-rotating night shift workers 25Females25Males 18-65years with existing cardiometabolic risk factors At the end of each 4-week outpatient condition TRE vs Control with an intervening 4-week washout period we will conduct rigorous 3-day inpatient assessment to determine the impact of plasma lipid reduction via TRE in chronic night shift workers on 1 vascular function and blood pressure and 2 whole body and muscle-specific insulin sensitivity glucose homeostasis and muscle lipid accumulation
Achievement of these aims will identify a potential mechanism by which circadian misalignment impairs vascular function and insulin sensitivity elevated plasma lipids as well as a non-pharmacological tool TRE that could be implemented to reduce cardiometabolic disease risk in populations at elevated risk in 20 of the US workforce who work nonstandard hours including military personnel police paramedics firefighters pilots medical doctors and nurses as well as people with sleep and circadian disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None