Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892211
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-07
First Post:
2023-05-09
Brief Title:
LINE-1 and Alu Methylation Levels Among Middle Aged Women With Low Cardiovascular Risk Profile in Respect of Menopausal Hot Flashes
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
The Pilot Study of LINE-1 and Alu Methylation Levels Among Middle Aged Women With Low Cardiovascular Risk Profile in Respect of Menopausal Hot Flashes
Status:
ACTIVE_NOT_RECRUITING
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:
Vasomotor symptoms are the most common symptoms seen during climacterium The hypoestrogenic state causes dysfunction of hypothalamic preoptic area a thermoregulatory center The sympathetic overactivation during the hot flashes is associated with awakening during sleep and have a negative impact on cardiac indexes and vascular reactivity Therefore hot flashes are accepted as subclinical cardiovascular risk factor
The association between the severity of the hot flashes and cardiovascular risk may have an epigenetic background Recently methylation changes of DNA was found to be associated with clinical and subclinical cardiovascular disease risk atherosclerosis and hypertension etc A transposable element in the DNA Long interspersed nuclear elements LINE-1 was found to be hypomethylated in cases with ischemic heart disease and stroke Therefore the expression of repeating elements in the DNA LINE-1 and ALU may be considered as a mediator in the ischemic heart disease Until now menopausal age vasomotor symptoms and epigenetic and biological aging have been evaluated However the epigenetic impact of severe vasomotor symptoms in postmenopausal women with low cardiovascular disease risk profile has not been evaluated In this study we aimed to evaluate the epigenetic basis of cardiovascular disease risk for women with vasomotor symptoms which disturb sleep by assessing the methylation levels of ALU and LINE-1
The association between the severity of the hot flashes and cardiovascular risk may have an epigenetic background Recently methylation changes of DNA was found to be associated with clinical and subclinical cardiovascular disease risk atherosclerosis and hypertension etc A transposable element in the DNA Long interspersed nuclear elements LINE-1 was found to be hypomethylated in cases with ischemic heart disease and stroke Therefore the expression of repeating elements in the DNA LINE-1 and ALU may be considered as a mediator in the ischemic heart disease Until now menopausal age vasomotor symptoms and epigenetic and biological aging have been evaluated However the epigenetic impact of severe vasomotor symptoms in postmenopausal women with low cardiovascular disease risk profile has not been evaluated In this study we aimed to evaluate the epigenetic basis of cardiovascular disease risk for women with vasomotor symptoms which disturb sleep by assessing the methylation levels of ALU and LINE-1
Detailed Description:
Vasomotor symptoms are the most common symptoms seen during climacterium The hypoestrogenic state causes dysfunction of hypothalamic preoptic area a thermoregulatory center The variations in the range of thermoneutral zone determine the severity of the vasomotor symptoms Sympathetic overactivation during the hot flash and decreased rate of parasympathetic control on the heart rate are the main factors contributing to the cardiovascular disease risk The hot flashes which occur and cause awakening during sleep have negative impact on cardiac indexes and vascular reactivity Therefore vasomotor symptoms are accepted as subclinical cardiovascular risk factor
Hot flashes associated with nighttime awakenings were shown to increase systolic and diastolic blood pressure and decrease pre-ejection period Objectively recorded hot flashes and nighttime awakenings were found to be correlated white matter hyperintensities in the brain which show poor brain health In addition white matter hyperintensities may be considered as a cerebral small vascular disease and is associated with greater odds of having stroke and dementia
Among postmenopausal women cardiovascular disease is the most prevalent cause for mortality and morbidity It results from the interaction of environmental and genetic factors The association between the severity of hot flashes and cardiovascular risk may have an epigenetic background The global DNA methylations were found to be decreased in postmenopausal women with high cardiovascular disease risk Recently methylation changes of DNA was found to be associated with clinical and subclinical cardiovascular disease risk atherosclerosis and hypertension etc A transposable element in the DNA Long interspersed nuclear elements LINE-1 was found to be hypomethylated in cases with ischemic heart disease and stroke Therefore the expression of repeating elements in the DNA LINE-1 and ALU may be considered a mediator in the ischemic heart disease Until now menopausal age vasomotor symptoms and epigenetic and biological aging have been evaluated However the epigenetic impact of severe vasomotor symptoms in postmenopausal women with low cardiovascular disease risk profile has not been evaluated In this study we aimed to evaluate the epigenetic basis of cardiovascular disease risk for women who have low cardiovascular disease risk profile at baseline and have vasomotor symptoms which disturb sleep by assessing the methylation levels of ALU and LINE-1
Hot flashes associated with nighttime awakenings were shown to increase systolic and diastolic blood pressure and decrease pre-ejection period Objectively recorded hot flashes and nighttime awakenings were found to be correlated white matter hyperintensities in the brain which show poor brain health In addition white matter hyperintensities may be considered as a cerebral small vascular disease and is associated with greater odds of having stroke and dementia
Among postmenopausal women cardiovascular disease is the most prevalent cause for mortality and morbidity It results from the interaction of environmental and genetic factors The association between the severity of hot flashes and cardiovascular risk may have an epigenetic background The global DNA methylations were found to be decreased in postmenopausal women with high cardiovascular disease risk Recently methylation changes of DNA was found to be associated with clinical and subclinical cardiovascular disease risk atherosclerosis and hypertension etc A transposable element in the DNA Long interspersed nuclear elements LINE-1 was found to be hypomethylated in cases with ischemic heart disease and stroke Therefore the expression of repeating elements in the DNA LINE-1 and ALU may be considered a mediator in the ischemic heart disease Until now menopausal age vasomotor symptoms and epigenetic and biological aging have been evaluated However the epigenetic impact of severe vasomotor symptoms in postmenopausal women with low cardiovascular disease risk profile has not been evaluated In this study we aimed to evaluate the epigenetic basis of cardiovascular disease risk for women who have low cardiovascular disease risk profile at baseline and have vasomotor symptoms which disturb sleep by assessing the methylation levels of ALU and LINE-1
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