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

NCT00448526 | Terminated DMC

• 1 other identifier: H8-H-077
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• urinary albumin and protein excretion

• % change of urinary albumin and protein excretion from baseline

Interventions

low protein diet BEHAVIORAL

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanazawa Medical University: lead

Related Publications (2)

• 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.

  PMID: 36594428 DERIVED

• 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.

  PMID: 19652945 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ryuichi Kikkawa, M.D.

  Shiga University of Medical Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2007
• First Posted: March 19, 2007
• Study Start: December 1, 1997
• Study Completion: August 1, 2006
• Last Updated: March 19, 2007

Record last verified: 2007-03