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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00448526

Acronym

LPD

Enrollment

Unknown

Registered

2007-03-19

Start date

1997-12-31

Completion date

2006-08-31

Last updated

2007-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALlow protein diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
annual change of Ccr	—
incidence rate of the doubling of sCr	—
time to the doubling of sCr	—
annual change of GFR	—
annual change of 1/Cr	—

Secondary

Measure	Time frame
% change of urinary albumin and protein excretion from baseline	—
urinary albumin and protein excretion	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026