Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
Not Applicable
Terminated
- Conditions
- Diabetic Nephropathies
- Registration Number
- NCT00448526
- Lead Sponsor
- Kanazawa Medical University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method annual change of GFR annual change of Ccr annual change of 1/Cr time to the doubling of sCr incidence rate of the doubling of sCr
- Secondary Outcome Measures
Name Time Method urinary albumin and protein excretion % change of urinary albumin and protein excretion from baseline