Identification of New Biomarkers to Explore Pathology of Renal Tissue and to Predict Outcomes of Diabetic Nephropathy Study
- Conditions
- Diabetes Diabetic nephropathy
- Registration Number
- JPRN-UMIN000024530
- Lead Sponsor
- Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Nephrology, Rheumatology, Endocrinology and Metabolism
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Not provided
1. Patients with diabetes due to other reasons except for type 1 and 2 diabetes, such as steroid-induced diabetes, Cushing syndrome, and genetic diabetes 2. Female in pregnancy or with possibility of pregnancy 3. Patients with high risk of renal biopsy High risk is defined as any one of the following 6 criteria. i. Platelet count < 100,000 (/ul) or definite disordered coagulation ii. Usage of antiplatelet drug and anticoagulated drug which can not be stopped temporarily. iii. Progressive anemia except for renal anemia iv. Patients who can not keep a position in bed during renal biopsy. v. Morphologic problems revealed by image information Specifically, multiple cysts on the puncture line, renal cortex thickness < 10mm, and so on. vi. Patients whom primary physician clinically defined as patients at high risk because of other reasons. 4. Patients under the emergency situations, such as life-threatening and infectious situation. 5. Baseline eGFR < 15ml/min/1.73m2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eGFR 30-40% decline from baseline
- Secondary Outcome Measures
Name Time Method 1. Investigation of clinicopathologic indocators of renal progression in diabetic nephropathy I. eGFR decline > 3-5 ml/min/1.73m2/year II. Commencement of dialysis or renal transplantation because of end stage renal disease III. Development of albuminuric stage 2. Investigation of other major complications of diabetes I.Development of diabetic retinopathy II.CVD event III.Death 3. Exploration of new biomarkers to predict diabetic nephropathy in patients with diabetes. I. Diabetic nephrpathy vs no renal disease II. Diabetic nephropathy vs other renal diseases * Investigation of biomarmers to differenciate I and II