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

Diabetic Nephropathies Clinical Trial

— LPD  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00448526
• Other study ID #: H8-H-077
• Status: Terminated
• Phase: N/A
• First received: March 16, 2007
• Last updated: March 16, 2007
• Start date: December 1997
• Est. completion date: August 2006

Study information

• Verified date: March 2007
• Source: Kanazawa Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: August 2006
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Behavioral:
• low protein diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kanazawa Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	annual change of GFR
Primary	annual change of Ccr
Primary	annual change of 1/Cr
Primary	incidence rate of the doubling of sCr
Primary	time to the doubling of sCr
Secondary	urinary albumin and protein excretion
Secondary	% change of urinary albumin and protein excretion from baseline