NCT00253786

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

Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Okayama University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Type 2 Diabetes Mellitus
• Diabetic Nephropathy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2005-11-11
• Primary completion: 2014-11-27
• Completion: 2014-11-27
• First posted: 2005-11-15
• Last updated: 2019-07-23

Locations

1 site across 1 country: Japan