Early-stage renal failure due to type 2 diabetic nephropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) outpatient 2) age over 20 3) estimated GFR (eGFR), calculated by MDRD equation, is between 30 mL/min and 60 mL/min. the ratio of latest eGFR (eGFR2) and eGFR over 3 months before the day of eGFR2 measurement (eGFR1) is under 0.95 (eGFR2/eGFR1 <= 0.95) 4) over excretion of proteinuria (+- <= using paper test, or 30 mg/dL <= the concentration of proteinuria) 5) therapy with Angiotensin converting enzyme inhibitor and/or Angiotensin II receptor blockade continuously 6) periodical diet therapy 7) diabetic retinopathy
Exclusion criteria
Exclusion criteria: 1) stenosis of alimentary tract 2) severe constipation 3) event of myocardial infarction, cerebral infarction and cerebral hemorrhage within three months 4) malignant disease within 5 years 5) severe nephrosis (serum albumin < 2 g/dL) 6) pregnancy, patient's hope to be pregnant or breast-feeding 7) very poor control of diabetes mellitus (10.0 % <= HbA1c for six months continuously) 8) the case, regarded as unsuitable by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Doubling of the serum creatinine concentration. More than 15 mL/min of the decrement of estimated GFR. The need for long-term dialysis. Renal transplantation. Death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization from cardiovascular causes. The changes in the level of estimated GFR, serum creatinine and proteinuria. | — |
Countries
Japan
Contacts
Office of the OKINAWA Study Department of Endocrinology and Metabolism, University of the Ryukyus School of Medicine