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Controlled Study to Evaluate Efficacy and Safety of α-KA Tab With Low Protein Diet (LPD) in Delaying the Progress of Type 2 Diabetic Nephropathy (DN)

NCT00363987 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2010-09-02

No results posted yet for this study

Summary

Current expert opinion based consensus guidelines recommend usage of α-Keto analogues of essential amino acids in the diet of diabetic nephropathy patients, along with restricted protein diets. This study is designed to explore whether alpha-Keto Acid supplementation with low protein diet will retard progression of type 2 diabetic nephropathy and also to assess effects of such supplemented diets on nutritional and other parameters in this patient group.

Conditions

  • Diabetic Nephropathy

Interventions

DRUG

Ketosteril®

1 tablet Ketosteril/5kgBW/d

OTHER

diabetic diet

Energy 30-35 Kcal/kg BW/d + protein 0.8 g/kg BW/d

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Shantan Lin · Shanghai Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-12-31
Completion
2009-06-30

Countries

  • China

Study Locations

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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 NCT00363987 on ClinicalTrials.gov