---
title: Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
nct_id: NCT00448526
overall_status: TERMINATED
phase: NA
sponsor: Kanazawa Medical University
study_type: INTERVENTIONAL
primary_condition: Diabetic Nephropathies
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00448526.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00448526"
ct_last_update_post_date: 2007-03-19
last_seen_at: "2026-05-12T07:33:02.413Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy

**NCT ID:** [NCT00448526](https://clinicaltrials.gov/study/NCT00448526)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Terminated: recruiting or enrolling participants has halted and will not resume because low protein diet is not feasible nor efficious.
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Lead Sponsor:** Kanazawa Medical University
- **Conditions:** Diabetic Nephropathies
- **Start Date:** 1997-12
- **Completion Date:** 2006-08
- **CT.gov Last Update:** 2007-03-19

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 65 Years
- **Sex:** ALL

```
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
```

## Interventions

- **low protein diet** (BEHAVIORAL)

## Primary Outcomes

- **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

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00448526.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00448526*  
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