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

NCT00253786 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2019-07-23

No results posted yet for this study

Summary

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

Conditions

Interventions

OTHER

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

OTHER

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)

Sponsors & Collaborators

  • Okayama University

    lead OTHER

Principal Investigators

  • Hirofumi Makino, M.D. · Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-11
Primary Completion
2014-11-27
Completion
2014-11-27

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00253786 on ClinicalTrials.gov