Sleep ApneaSLEEPNCT04549324
Sleep Apnea, Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy
An observational study of Sleep Apnea and Diabetic Nephropathy Type 2, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Diabetic Nephropathy Type 2, Coronary Atheroscleroses
- How many people
- 74 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 24 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic adult patients (Type 2) with scheduled check-ups at Steno Diabetes Center Aarhus, or Department of Renal Medicine on Aarhus University Hospital can be included in the study if they satisfy all eligible criteria. Additionally, patients from the GP and within the including area of Aarhus University Hospital were invited to participate in the study. The study cohort will consist of: Generel characteristics of both groups: - Diabetes Mellitus Type 2 with an eGFR between 10-60 ml/min/1,73 m^2 Sleep Apnea: 1. 40 patients with an apnea/hyponea-index above ≥ 15 per hour. Non-Sleep Apnea: 2. 40 patients with an apnea/hyponea-index below < 5 per hour.
Who may be able to join
- ≥ 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Sleep Apnea Syndromes, Coronary Artery Disease, Heart Failure, Kidney Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Apnea (AHI ≥ 15 per hour) | Patients with moderate/severe sleep apnea (Apnea/hypopnea-index ≥ 15 per hour). | |
| Non-Sleep Apnea (AHI < 5 per hour) | Patients without sleep apnea (Apnea/hypopnea-index < 5 per hour). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between sleep apnea and coronary atherosclerosis (Agatston Score) measured with cardiac CT-scan in patients with diabetic nephropathy.
The degree of atherosclerosis in the coronary artery walls is evaluated by cardiac CT-scan and subsequent quantified by Agatston score. Patients with an estimated glomerular filtration rate (eGFR) ≤ 25 ml/min/1,73 m2 is scanned without contrast whereas patients with an eGFR 26-60 ml/min/1,73 m2 are screened with contrast.
All Agatston scoring will be performed by a cardiologist blinded to information on patient biochemical characteristics and AHI. The only biochemical parameter which the cardiologist is not blinded to is eGFR.
Measured: Cardiac CT-scan will be performed no later than 1 month after inclusion. All Agatston scores will be estimated straight after the cardiac CT-scan.
The association between sleep apnea and systolic function in patients with diabetic nephropathy.
All patients included in the study will undergo transthoracic echocardiography. Systolic function is evaluated by two-dimensional automated evaluation of ejection fraction (2-D auto-EF).
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
The association between sleep apnea and diastolic heart failure in patients with diabetic nephropathy.
All patients included in the study will undergo transthoracic echocardiography. Diastolic function is evaluated by E/e´.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
The association between sleep apnea and systolic function in patients with diabetic nephropathy.
All patients included in the study will undergo transthoracic echocardiography. Systolic function is evaluated by Left Ventricular Global Longitudinal Strain (GLS).
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Secondary outcomes (30)
The association between sleep apnea and coronary plaque volume in patients with diabetic nephropathy.
Coronary plaque volume is estimated by a cardiac CT-scan with contrast.
All coronary plaque volume analysing will be performed by a cardiologist blinded to information on patient biochemical characteristics and AHI. The only biochemical parameter which the cardiologist is not blinded to is eGFR.
Measured: Cardiac CT-scan will be performed no later than 1 month after inclusion.
Association of sleep apnea and aortic stiffness (defined as Pulse Wave Velocity (PWV)) in patients with diabetic nephropathy.
To get a non-invasive estimate of the aortic stiffness, measurement of Pulse Wave Velocity (PWV) (carotid-femoral and carotid-radial) will be performed. PWV will be recorded with the Sphygmocor® device according to regular protocol. If possible, two acceptable measurements will be conducted for each included patient. Calculation of PWV will be performed automatically by the device using a previously published formula.
Measured: PWV is performed the same day as the patient is included.
Association between Matrix Gla Protein (MGP) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. MGP, a novel biochemical marker of arterial calcification, will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Calcification propensity score (T50test) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. Calcification propensity score (T50test) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between 25-OH-Vitamin D(D3+D2) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. 25-OH-Vitamin D(D3+D2) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) will be collected and analysed in all patients
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021.
Association between Sclerostin and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy., Sclerostin will be collected and analysed in all patients
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between osteoprotegerin and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy., osteoprotegerin will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between BsAP (bone-specific alkaline phosphatase) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy., BsAP (bone-specific alkaline phosphatase) will be collected and analysed in all patients
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between TRAP5B (tartrate-resistant acid phosphatase 5b) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy, TRAP5B (tartrate-resistant acid phosphatase 5b) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between P1NP (procollagen type 1 N propeptide) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy., P1NP (procollagen type 1 N propeptide) will be collected and analysed in all patients
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between LVEDd (Left ventricular end diastolic diameter) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between LVEDs (Left ventricular end systolic diameter) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between IVSd (Interventricular Septal Thickness at Diastole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between IVSs (Interventricular Septal Thickness at Systole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between PWTd (Posterior wall thickness at end-diastole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between PWTs (Posterior wall thickness at end-systole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (sinus valsalva) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (Ascendens) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (Abdominalis) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between maximum Vena Cava Inferior diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between minimum Vena Cava Inferior diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Early mitral inflow velocity (E) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Late mitral inflow velocity (A) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between E/A-ratio as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Deceleration time of early diastolic transmittal flow (dtE) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Right ventricular diameter (RVD) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.
The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between left atrial volume (LAV) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between 2D atrial global strain as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. The echocardiographic-clinician is blinded to AHI-status.
Measured: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Oct 2020
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels H. Buus, MD PhD DMSc, Study chair, Department of Renal diseases, Aarhus University HospitalSebastian Nielsen, MD student, Principal investigator, Department of Renal diseases, Aarhus University HospitalJakob T. Nyvad, MD, Study chair, The Clinic of Hypertension, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549324
- Sponsor's protocol ID
- 1-10-72-122-20
- Acronym
- SLEEP
- Status last verified
- Oct 2021
- First submitted
- 8 Sep 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD. pas
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea, Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy
- ClinicalTrials.gov ID
- NCT04549324
- Acronym / sponsor ID
- SLEEP / 1-10-72-122-20
- Conditions
- Sleep Apnea, Diabetic Nephropathy Type 2, Coronary Atheroscleroses, Heart Insufficiency, Arterial Stiffness, Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Apnea (AHI ≥ 15 per hour) | – | –Patients with moderate/severe sleep apnea (Apnea/hypopnea-index ≥ 15 per hour). |
| Non-Sleep Apnea (AHI < 5 per hour) | – | –Patients without sleep apnea (Apnea/hypopnea-index < 5 per hour). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic adult patients (Type 2) with scheduled check-ups at Steno Diabetes Center Aarhus, or Department of Renal Medicine on Aarhus University Hospital can be included in the study if they satisfy all eligible criteria. Additionally, patients from the GP and within the including area of Aarhus University Hospital were invited to participate in the study. The study cohort will consist of: Generel characteristics of both groups: - Diabetes Mellitus Type 2 with an eGFR between 10-60 ml/min/1,73 m^2 Sleep Apnea: 1. 40 patients with an apnea/hyponea-index above ≥ 15 per hour. Non-Sleep Apnea: 2. 40 patients with an apnea/hyponea-index below < 5 per hour.
Key inclusion criteria (2 listed)
- ≥ 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).
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The association between sleep apnea and coronary atherosclerosis (Agatston Score) measured with cardiac CT-scan in patients with diabetic nephropathy.
Time frame: Cardiac CT-scan will be performed no later than 1 month after inclusion. All Agatston scores will be estimated straight after the cardiac CT-scan.
The degree of atherosclerosis in the coronary artery walls is evaluated by cardiac CT-scan and subsequent quantified by Agatston score. Patients with an estimated glomerular filtration rate (eGFR) ≤ 25 ml/min/1,73 m2 is scanned without contrast whereas patients with an eGFR 26-60 ml/min/1,73 m2 are screened with contrast. All Agatston scoring will be performed by a cardiologist blinded to information on patient biochemical characteristics and AHI. The only biochemical parameter which the cardiologist is not blinded to is eGFR.
The association between sleep apnea and systolic function in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
All patients included in the study will undergo transthoracic echocardiography. Systolic function is evaluated by two-dimensional automated evaluation of ejection fraction (2-D auto-EF). The echocardiographic-clinician is blinded to AHI-status.
The association between sleep apnea and diastolic heart failure in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
All patients included in the study will undergo transthoracic echocardiography. Diastolic function is evaluated by E/e´. The echocardiographic-clinician is blinded to AHI-status.
The association between sleep apnea and systolic function in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
All patients included in the study will undergo transthoracic echocardiography. Systolic function is evaluated by Left Ventricular Global Longitudinal Strain (GLS). The echocardiographic-clinician is blinded to AHI-status.
30 secondary outcomes
The association between sleep apnea and coronary plaque volume in patients with diabetic nephropathy.
Time frame: Cardiac CT-scan will be performed no later than 1 month after inclusion.
Association of sleep apnea and aortic stiffness (defined as Pulse Wave Velocity (PWV)) in patients with diabetic nephropathy.
Time frame: PWV is performed the same day as the patient is included.
Association between Matrix Gla Protein (MGP) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Calcification propensity score (T50test) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between 25-OH-Vitamin D(D3+D2) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021.
Association between Sclerostin and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between osteoprotegerin and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between BsAP (bone-specific alkaline phosphatase) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between TRAP5B (tartrate-resistant acid phosphatase 5b) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between P1NP (procollagen type 1 N propeptide) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between LVEDd (Left ventricular end diastolic diameter) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between LVEDs (Left ventricular end systolic diameter) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between IVSd (Interventricular Septal Thickness at Diastole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between IVSs (Interventricular Septal Thickness at Systole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between PWTd (Posterior wall thickness at end-diastole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between PWTs (Posterior wall thickness at end-systole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (sinus valsalva) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (Ascendens) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (Abdominalis) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between maximum Vena Cava Inferior diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between minimum Vena Cava Inferior diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Early mitral inflow velocity (E) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Late mitral inflow velocity (A) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between E/A-ratio as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Deceleration time of early diastolic transmittal flow (dtE) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Right ventricular diameter (RVD) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between left atrial volume (LAV) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between 2D atrial global strain as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No. IPD. pas
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels H. Buus, MD PhD DMSc study chair
Department of Renal diseases, Aarhus University Hospital
Sebastian Nielsen, MD student principal investigator
Department of Renal diseases, Aarhus University Hospital
Jakob T. Nyvad, MD study chair
The Clinic of Hypertension, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Diabetic Nephropathy Type 2, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between sleep apnea and coronary atherosclerosis (Agatston Score) measured with cardiac CT-scan in patients with diabetic nephropathy. (time frame: Cardiac CT-scan will be performed no later than 1 month after inclusion. All Agatston scores will be estimated straight after the cardiac CT-scan.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.