Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy (LPD)

Kanazawa Medical University

Status: Terminated

Conditions: Diabetic Nephropathies

Treatments: Behavioral: low protein diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00448526

H8-H-077

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)