Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy

Kanazawa Medical University

Overview

Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as a mainstay of nutritional management. We here assessed the role of low protein diet in renal function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of 5 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Diabetic Nephropathies

Interventions

low protein dietBEHAVIORAL

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus * Urinary protein excretion 1-10 g/day * Serum Cr \<2.0 mg/dl * With diabetic retinopathy \> SDR * Normal protein intake instruction * Patients whose consent is obtained at \>20 or age =\<65 Exclusion Criteria: * Type 1 Diabetes Mellitus * Non-diabetic nephropathy * Urinary tract infection * Congestive heart failure * Unstable angina * Myocardial infarction * Stroke * Severe hepatopathy * Life threatening disease such as malignant tumor * Patients on ACE-I and or ARB treatment * Patients on instruction of low protein diet * BW\< 80% of IBW * Pregnant, lactating, and probably pregnant patients * Patients judged as being inappropriate fir the subjects

Outcomes

Primary Outcomes

annual change of GFR

annual change of Ccr

annual change of 1/Cr

incidence rate of the doubling of sCr

time to the doubling of sCr

Secondary Outcomes

urinary albumin and protein excretion

% change of urinary albumin and protein excretion from baseline

Data from ClinicalTrials.gov

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