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Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy

NCT01521910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2012-01-31

No results posted yet for this study

Summary

The purpose of the investigators study was to determine the effect of dietary protein restriction on survival and progression to end stage renal disease (ESRD) in diabetic nephropathy.

Conditions

  • Type 1 Diabetes Mellitus With Diabetic Nephropathy

Interventions

DIETARY_SUPPLEMENT

low protein diet

An iso-caloric low protein diet of 0.6 g/kg/day was prescribed during the whole study duration. The same dietician gave nutritional advices at least every three months during the whole study period. Patients were also seen by the same doctor during each visit for the whole study period. Supplementation of Calcium of 500mg/day. Urine albumin losses \>= 2 g/day wre replaced by increasing dietary protein on a gram-for-gram basis, only if the patient was compliant with the prescribed low-protein diet.

DIETARY_SUPPLEMENT

normal protein diet

The patients pre-study diet during the whole study period Patients were also seen by the same doctor during each visit for the whole study period.

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Henrik P Hansen, MD · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-04-30
Primary Completion
2000-06-30
Completion
2000-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01521910 on ClinicalTrials.gov