The DIAbetes COhoRtE
- Conditions
- Chronic kidney diseaseE11N18Type 2 diabetes mellitus
- Registration Number
- DRKS00010498
- Lead Sponsor
- niversitätsklinikum Regensburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3000
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.
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br>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 Outcome Measures
Name Time Method 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). <br>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.