Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy

Okayama University312 enrolled

Overview

Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy

Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

312

Conditions

Type 2 Diabetes Mellitus Diabetic Nephropathy

Interventions

Intensive multifactorial therapyOTHER

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

Standard therapyOTHER

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)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Okayama University Hospital

Okayama, Japan

Outcomes

Primary Outcomes

Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A

Time frame: 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

Time frame: 5 years

Secondary Outcomes

GFR in Protocol A

Time frame: 5 years

Cardiovascular event in Protocol A

Time frame: 5 years

Progression of retinopathy in Protocol A

Time frame: 5 years

Urinary albumin/creatinine ratio in Protocol A

Time frame: 5 years

Proteinuria (24 h collection sample) in Protocol A

Time frame: 5 years

GFR in Protocol B

Time frame: 5 years

Cardiovascular event in Protocol B

Time frame: 5 years

Progression of retinopathy in Protocol B

Time frame: 5 years

Urinary albumin/creatinine ratio in Protocol B

Time frame: 5 years

Urinary protein/creatinine ratio in Protocol B

Data from ClinicalTrials.gov

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