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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive multifactorial therapy (Protocol A) | Experimental | Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female. |
|
| Standard therapy (Protocol A) | Active Comparator | Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female. |
|
| Intensive multifactorial therapy (Protocol B) | Experimental | Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female. |
|
| Standard therapy (Protocol B) | Active Comparator | Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive multifactorial therapy | Other | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| GFR in Protocol A | 5 years | |
| Cardiovascular event in Protocol A | 5 years | |
| Progression of retinopathy in Protocol A |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hirofumi Makino, M.D. | Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39171639 | Derived | Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3. | |
| 36645291 | Derived | Hodson EM, Cooper TE. Altered dietary salt intake for preventing diabetic kidney disease and its progression. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD006763. doi: 10.1002/14651858.CD006763.pub3. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003928 | Diabetic Nephropathies |
| D003920 | Diabetes Mellitus |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard therapy | Other | 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) |
|
| 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 |
| Cardiovascular event in Protocol B | 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 |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |