Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624046
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Circadian Mechanisms Glucose and CV Risks in T1D
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
People with type 1 diabetes are disproportionately affected by cardiovascular disease CVD Short and irregular sleep have been associated with cardiovascular risk in this population Improving sleep regularity has been associated with improved glycemic markers however mechanisms by which improving sleep regularity improves metabolic and cardiovascular health is not known The investigators propose to conduct a mechanistic study using a sleep stability manipulation This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D
Detailed Description:
People with type 1 diabetes T1D are disproportionately affected by cardiovascular disease CVD CVD is a leading cause of death in T1D contributing to 40 of mortality Sleep is recognized by both the American Heart Association and the American Diabetes Association as a critical health behavior to maintain glycemic control and reduce CVD risk Short andor irregular sleep have been associated with reduced glycemic control and non-dipping blood pressure in T1D both of which are predictors of CV events Emerging data suggest that behavioral sleep interventions targeting short or irregular sleep led to improved glycemic parameters However little is known about the mechanism by which improving sleep duration andor regularity improves glycemic control and reduces CV risk in T1D The investigators and others have shown that people with T1D often experience poor sleep health including inadequate sleep duration sleep irregularity and poor sleep quality The goals of this study are to examine the mechanisms by which improving sleep regularity through behavioral sleep intervention affects glycemic control and CVD risks in T1D adults The investigators propose to extend our previous research by conducting a mechanistic study using a sleep stability manipulation The investigators hypothesize that sleep stability impacts glycemic control and CV outcomes by improving circadian regulation The investigators will conduct a 4-week behavioral sleep stability intervention in 80 T1D adults with irregular sleep utilizing a sleep prepost design Circadian regulation will be assessed by dim-light melatonin onset DLMO melatonin metabolite amplitude overnight urinary 6-sulfatoxymelatonin levels actigraphy-derived rest-activity rhythm endothelial cell CLOCK gene mRNA expression and known zeitgebers of the central and peripheral circadian clocks light exposure meal timing Main glycemic outcomes will be assessed by CGM A1C and assessment of insulin sensitivity Main CV outcomes will include 24h blood pressure and endothelial FMD and other secondary vascular measures pulse wave velocity carotid intima media thickness and echocardiographic parameters Sleep will be objectively recorded All parameters will be measured at baseline and end of intervention This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D
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