Effect of Low Protein Diet in Preventing the Progression... | NCT00448526

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

NCT00448526

Sponsor

Kanazawa Medical University

Status

Terminated

Last Update Posted

Mar 19, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Diabetic Nephropathies

Interventions

low protein diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated: recruiting or enrolling participants has halted and will not resume because low protein diet is not feasible nor efficious.

Expanded Access Info

Start Date

Dec 1997

Primary Completion Date

Not provided

Completion Date

Aug 2006

First Submitted Date

Mar 16, 2007

First Submission Date that Met QC Criteria

Mar 16, 2007

First Posted Date

Mar 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2007

Last Update Posted Date

Mar 19, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
low protein diet	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
urinary albumin and protein excretion
% change of urinary albumin and protein excretion from baseline

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ryuichi Kikkawa, M.D.	Shiga University of Medical Science	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36594428	Derived	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.
19652945	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747