Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04549324
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2020-09-08
Brief Title:
Sleep Apnea Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Sleep Apnea Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy
Status:
COMPLETED
Status Verified Date:
2021-10
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:
SLEEP
Brief Summary:
Background
Diabetes and especially diabetic kidney disease is associated with the development of cardiovascular disease such as calcification in the coronary arteries and heart failure Sleep apnea is frequent among patients with diabetes and diabetic kidney disease and sleep apnea itself is a solitary risk factor in the development of cardiovascular disease Nonetheless sleep apnea is underdiagnosed in diabetes patients because of a discrepancy between sleep apnea severity and actual oxygen deficiency symptoms which makes the diagnosis difficult For that reason many diabetics have undiagnosed sleep apnea together with cardiovascular disease Early discovery of sleep apnea among high risk diabetic patients may therefore be considered crucial before cardiovascular complications develop For this reason sleep apnea screening of high-risk diabetics can possibly improve early diagnostics of cardiovascular disease
Aim
This study will seek to establish the association between obstructive sleep apnea OSA and coronary calcification and heart failure in patients with diabetic kidney disease The basic hypothesis of the study is that patients with diabetic kidney disease and concurrent OSA have a higher prevalence and severity of coronary calcification and heart failure compared to patients without OSA
Methods
Diabetic adult patients with scheduled check-ups at Steno Diabetes Center Aarhus or Department of Renal Medicine on Aarhus University Hospital will be included in the study
Firstly all included patients are screened for sleep apnea with the devices SomnoTouch and ApneaLink Based on the sleep apnea determination 40 patients with moderate-severe sleep apnea are compared with 40 patients without sleep apnea In both groups the patients are examined for calcification in the coronary vessels using a CT-scan while the function of the heart is examined by ultrasound echocardiography The stiffness of aorta is measured and performed using radial artery tonometry SphygmoCor
Furthermore range of blood- and urine samples will be performed
The perspectives are that patients with diabetes should be regularly evaluated for sleep apnea and that patients with moderatesevere sleep apnea should undergo further examination for cardiovascular disease even though the patients dont display any symptoms of either cardiovascular disease or sleep apnea
Diabetes and especially diabetic kidney disease is associated with the development of cardiovascular disease such as calcification in the coronary arteries and heart failure Sleep apnea is frequent among patients with diabetes and diabetic kidney disease and sleep apnea itself is a solitary risk factor in the development of cardiovascular disease Nonetheless sleep apnea is underdiagnosed in diabetes patients because of a discrepancy between sleep apnea severity and actual oxygen deficiency symptoms which makes the diagnosis difficult For that reason many diabetics have undiagnosed sleep apnea together with cardiovascular disease Early discovery of sleep apnea among high risk diabetic patients may therefore be considered crucial before cardiovascular complications develop For this reason sleep apnea screening of high-risk diabetics can possibly improve early diagnostics of cardiovascular disease
Aim
This study will seek to establish the association between obstructive sleep apnea OSA and coronary calcification and heart failure in patients with diabetic kidney disease The basic hypothesis of the study is that patients with diabetic kidney disease and concurrent OSA have a higher prevalence and severity of coronary calcification and heart failure compared to patients without OSA
Methods
Diabetic adult patients with scheduled check-ups at Steno Diabetes Center Aarhus or Department of Renal Medicine on Aarhus University Hospital will be included in the study
Firstly all included patients are screened for sleep apnea with the devices SomnoTouch and ApneaLink Based on the sleep apnea determination 40 patients with moderate-severe sleep apnea are compared with 40 patients without sleep apnea In both groups the patients are examined for calcification in the coronary vessels using a CT-scan while the function of the heart is examined by ultrasound echocardiography The stiffness of aorta is measured and performed using radial artery tonometry SphygmoCor
Furthermore range of blood- and urine samples will be performed
The perspectives are that patients with diabetes should be regularly evaluated for sleep apnea and that patients with moderatesevere sleep apnea should undergo further examination for cardiovascular disease even though the patients dont display any symptoms of either cardiovascular disease or sleep apnea
Detailed Description:
None
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