Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy
NCT ID: NCT00253786
Last Updated: 2019-07-23
Study Results
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Basic Information
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COMPLETED
NA
312 participants
INTERVENTIONAL
2005-11-11
2014-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intensive multifactorial therapy (Protocol A)
Protocol A: serum creatinine \<1.2 mg/dl in male and \<1.0 mg/dl in female.
Intensive 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
Standard therapy (Protocol A)
Protocol A: serum creatinine \<1.2 mg/dl in male and \<1.0 mg/dl in female.
Standard 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)
Intensive multifactorial therapy (Protocol B)
Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
Intensive 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
Standard therapy (Protocol B)
Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
Standard 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)
Interventions
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Intensive 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
Standard 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)
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
75 Years
ALL
No
Sponsors
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Okayama University
OTHER
Responsible Party
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Kenichi Shikata
Professor
Principal Investigators
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Hirofumi Makino, M.D.
Role: PRINCIPAL_INVESTIGATOR
Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Locations
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Okayama University Hospital
Okayama, , Japan
Countries
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References
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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.
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.
Other Identifiers
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DNETT-Japan
Identifier Type: -
Identifier Source: org_study_id
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