search
Back to results

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

Primary Purpose

Diabetic Nephropathies

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low protein diet
Sponsored by
Kanazawa Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Nephropathies focused on measuring Low protein diet, type 2 Diabetic nephropathy, Comparing the effect of Low protein Diet on diabetic nephropathy to that of normal protein diet

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 Outcome Measures

    urinary albumin and protein excretion
    % change of urinary albumin and protein excretion from baseline

    Full Information

    First Posted
    March 16, 2007
    Last Updated
    March 16, 2007
    Sponsor
    Kanazawa Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00448526
    Brief Title
    Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
    Acronym
    LPD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2007
    Overall Recruitment Status
    Terminated
    Why Stopped
    Terminated: recruiting or enrolling participants has halted and will not resume because low protein diet is not feasible nor efficious.
    Study Start Date
    December 1997 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kanazawa Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Nephropathies
    Keywords
    Low protein diet, type 2 Diabetic nephropathy, Comparing the effect of Low protein Diet on diabetic nephropathy to that of normal protein diet

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    low protein diet
    Primary Outcome Measure Information:
    Title
    annual change of GFR
    Title
    annual change of Ccr
    Title
    annual change of 1/Cr
    Title
    incidence rate of the doubling of sCr
    Title
    time to the doubling of sCr
    Secondary Outcome Measure Information:
    Title
    urinary albumin and protein excretion
    Title
    % change of urinary albumin and protein excretion from baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ryuichi Kikkawa, M.D.
    Organizational Affiliation
    Shiga University of Medical Science
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19652945
    Citation
    Koya D, Haneda M, Inomata S, Suzuki Y, Suzuki D, Makino H, Shikata K, Murakami Y, Tomino Y, Yamada K, Araki SI, Kashiwagi A, Kikkawa R; Low-Protein Diet Study Group. Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy: a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2037-45. doi: 10.1007/s00125-009-1467-8. Epub 2009 Aug 4.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs