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

NCT00253786 | Completed

• 1 other identifier: DNETT-Japan
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Diabetic Nephropathy

Keywords

diabetes; nephropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• GFR in Protocol A

  5 years

• Cardiovascular event in Protocol A

  5 years

• 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

Study Arms (4)

Intensive multifactorial therapy (Protocol A)

EXPERIMENTAL

Protocol A: serum creatinine \<1.2 mg/dl in male and \<1.0 mg/dl in female.

Other: Intensive multifactorial therapy

Standard therapy (Protocol A)

ACTIVE COMPARATOR

Protocol A: serum creatinine \<1.2 mg/dl in male and \<1.0 mg/dl in female.

Other: Standard therapy

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.

Other: Intensive multifactorial therapy

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.

Other: Standard therapy

Interventions

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

Intensive multifactorial therapy (Protocol A); Intensive multifactorial therapy (Protocol B)

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)

Standard therapy (Protocol A); Standard therapy (Protocol B)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes
• Urinary albumin-to-creatinine ratio: \>=300 mg/g creatinine twice in the first morning urine sample
• Serum creatinine level: =\<2.5 mg/dl
• Patients aged 20-75 years

You may not qualify if:

• Type 1 diabetes
• Hereditary diabetes or secondary diabetes
• Non-diabetic nephropathy
• Familial hypercholesterolemia
• Secondary hypertension
• Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
• Malignant tumor or life threatening disease
• History of angioedema
• Patients undergoing LDL apheresis
• Biliary system obstruction or severe liver injury
• Liver dysfunction
• Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
• Pregnant or nursing patients
• Others: patients who are not suitable for this trial

Sponsors & Collaborators

• Okayama University: lead

Study Sites (1)

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Related Publications (2)

• 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.

  PMID: 39171639 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.

  PMID: 36645291 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies; Diabetes Mellitus; Kidney Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hirofumi Makino, M.D.

  Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 15, 2005
• Study Start: November 11, 2005
• Primary Completion: November 27, 2014
• Study Completion: November 27, 2014
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

JP (1)