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

NCT ID: NCT00448526

Last Updated: 2007-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Nephropathies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

low protein diet

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kanazawa Medical University

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ryuichi Kikkawa, M.D.

Role: STUDY_DIRECTOR

Shiga University of Medical Science

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36594428 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19652945 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H8-H-077

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.