Sleep Apnea, Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy

NCT ID: NCT04549324

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-01-24

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 moderate/severe sleep apnea should undergo further examination for cardiovascular disease even though the patients don't display any symptoms of either cardiovascular disease or sleep apnea.

Conditions

Sleep Apnea; Diabetic Nephropathy Type 2; Coronary Atheroscleroses; Heart Insufficiency; Arterial Stiffness; Kidney Diseases; Vascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Sleep Apnea (AHI ≥ 15 per hour)

Patients with moderate/severe sleep apnea (Apnea/hypopnea-index ≥ 15 per hour).

No interventions assigned to this group

Non-Sleep Apnea (AHI < 5 per hour)

Patients without sleep apnea (Apnea/hypopnea-index \< 5 per hour).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years.
• Diabetes Mellitus Type 2 with an eGFR between 10-60 ml/min/1,73 m^2 (Equalling CKD-group 3, 4 and 5 non-dialysis).

Exclusion Criteria

• Known sleep apnea in continuous positive airway pressure(CPAP) treatment.
• Known mild sleep apnea (AHI 5-14) after the sleep apnea measurement.
• Participants with central apnea (> 50 % of central apnea episodes in the AHI ≥ 15 group.) or Cheyne Stokes after the sleep apnea measurement.
• < 4 hours of recording (ApneaLink)
• Known coronary arterial disease with previous revascularization (PCI or CABG)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels H. Buus, MD PhD DMSc

Role: STUDY_CHAIR

Department of Renal diseases, Aarhus University Hospital

Sebastian Nielsen, MD student

Role: PRINCIPAL_INVESTIGATOR

Department of Renal diseases, Aarhus University Hospital

Jakob T. Nyvad, MD

Role: STUDY_CHAIR

The Clinic of Hypertension, Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

1-10-72-122-20

Identifier Type: -

Identifier Source: org_study_id