Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
NCT ID: NCT00448526
Last Updated: 2007-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
INTERVENTIONAL
1997-12-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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low protein diet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
65 Years
ALL
No
Sponsors
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Kanazawa Medical University
OTHER
Principal Investigators
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Ryuichi Kikkawa, M.D.
Role: STUDY_DIRECTOR
Shiga University of Medical Science
References
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Jiang S, Fang J, Li W. Protein restriction for diabetic kidney disease. Cochrane Database Syst Rev. 2023 Jan 3;1(1):CD014906. doi: 10.1002/14651858.CD014906.pub2.
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.
Other Identifiers
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H8-H-077
Identifier Type: -
Identifier Source: org_study_id
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