E11 N18
Conditions
Interventions
Group 1: Obervational cohort. No Intervention. One patient group only.
Arm 1: At every study visit every 2 years for at least 10 years, a standardized examination (phenotyping) is performed by extensi
Sponsors
Universitätsklinikum Regensburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Ability to provide written informed consent, age =18 years, self-reported Caucasian ethnicity and prevalent diabetes mellitus type 2. Diabetes mellitus type 2 is defined as need for blood glucose lowering medication, at least two measurements of fasting glucose =126 mg/dL or a 2-hour glucose value in OGTT >200 mg/dL. Criteria for diagnosis of diabetes mellitus type 2 are obtained by self-report or from clinical records obtained from the patients’ health care provider.
Exclusion criteria
Exclusion criteria: Patients are excluded if, at baseline, they are on chronic renal replacement therapy (hemodialysis, peritoneal dialysis or transplantation), if, at baseline, there is a history of active malignancy (except those with basal cell carcinoma) within the last five years (prostatic cancer within the last two years), autoimmune disease potentially affecting kidney function (e.g. systemic lupus erythematodes), hemochromatosis, history of pancreoprivic or self-reported type 1 diabetes mellitus, acute infection or fever, pregnancy, chronic viral hepatitis or HIV-infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Since this is a prospective observational study without intervention, there is not one single primary outcome. Rather, patients are evaluated for prevalent single and combined outcomes at baseline and incident single and combined outcomes at every study follow-up visit, all listed below. All outcomes are determined at every study visit by questionnaire and medically adjudicated by the study team; where appropriate, the endpoints are determined by laboratory examinations (e.g. kidney function parameters). Outcomes: history of coronary artery disease (WHO Rose Angina Questionnaire), myocardial infarction, CABG, PCI, heart valve surgery, history of PAD (Edinburgh Questionnaire), vascular surgery or percutaneous intervention in peripheral and carotid vessels, cerebral ischemia, history of kidney disease and biopsy results, kidney function parameters (e.g. eGFR, annual eGFR decline, albuminuria, change in albuminuria over time, dipstick urine proteinuria). | — |
Secondary
| Measure | Time frame |
|---|---|
| Since this is a prospective observational study without intervention, there is not one single secondary outcome. Rather, patients are evaluated for prevalent single and combined outcomes at baseline and incident single and combined outcomes at every study follow-up visit, all listed below. All outcomes are determined at every study visit by questionnaire and medically adjudicated by the study team; where appropriate, the endpoints are determined by laboratory examinations (e.g. kidney function parameters). Outcomes: time to doubling of serum creatinine, time to incident renal replacement therapy, diabetic retinopathy requiring laser therapy, malignancy; incident hospitalization; incident mortality including cause. | — |
Countries
Germany
Contacts
Public ContactBettina Jung
Abteilung für Nephrologie, Universitätsklinikum Regensburg
Outcome results
None listed