Diabetic Nephropathy, Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, nephropathy
Brief summary
Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy
Detailed description
Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
Interventions
OTHERIntensive multifactorial therapy
Blood glucose control: HbA1c \< 6.2% Blood pressure control: SBP \< 125 mmHg, DBP: \< 75 mmHg Lipid profile: T-cho \< 180 mg/dl, LDL-cho \< 100 mg/dl, HDL-cho \>40 mg/dl Dietary intervention: TDEI \< 30 kcal/kg/day, sodium \< 5 g/day, protein \< 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care
OTHERStandard therapy
Blood glucose control: HbA1c \< 6.9% Blood pressure control: SBP \< 130 mmHg, DBP: \< 80 mmHg Lipid profile: T-cho \< 200 mg/dl, LDL-cho \< 120 mg/dl, HDL-cho \>40 mg/dl, Dietary intervention: TDEI \< 25-30 kcal/kg/day, sodium \< 6 g/day, protein \< 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)
Sponsors
Okayama University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with type 2 diabetes 2. Urinary albumin-to-creatinine ratio: \>=300 mg/g creatinine twice in the first morning urine sample 3. Serum creatinine level: =\<2.5 mg/dl 4. Patients aged 20-75 years
Exclusion criteria
1. Type 1 diabetes 2. Hereditary diabetes or secondary diabetes 3. Non-diabetic nephropathy 4. Familial hypercholesterolemia 5. Secondary hypertension 6. Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition 7. Malignant tumor or life threatening disease 8. History of angioedema 9. Patients undergoing LDL apheresis 10. Biliary system obstruction or severe liver injury 11. Liver dysfunction 12. Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors 13. Pregnant or nursing patients 14. Others: patients who are not suitable for this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A | 5 years |
| Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression of retinopathy in Protocol A | 5 years |
| Urinary albumin/creatinine ratio in Protocol A | 5 years |
| Proteinuria (24 h collection sample) in Protocol A | 5 years |
| GFR in Protocol B | 5 years |
| GFR in Protocol A | 5 years |
| Progression of retinopathy in Protocol B | 5 years |
| Urinary albumin/creatinine ratio in Protocol B | 5 years |
| Urinary protein/creatinine ratio in Protocol B | 5 years |
| Cardiovascular event in Protocol B | 5 years |
| Cardiovascular event in Protocol A | 5 years |
Countries
Japan
Outcome results
None listed