Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy
NCT ID: NCT01521910
Last Updated: 2012-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
1995-04-30
2000-06-30
Brief Summary
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Detailed Description
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After randomization an iso-caloric low-protein diet of 0.6 g/kg/day was prescribed to patients in the low-protein diet group. The usual-pro tein diet consisted of the patients' pre-study diet.
The planned duration of follow-up was four years, scheduled visits every three-months. All patients gave complete history of medication, underwent examination of weight, urinary albumin-, sodium- and urea excretion, serum albumin, serum urea, hemoglobin, hemoglobin A1c, blood pressure, serum total-cholesterol, high-density lipoprotein (HDL) cholesterol.
GFR, serum triglycerides,calcium and phosphorous, anthropometric measurements, nutritional status and smoking habits were evaluated every six months.
Dietary protein intake was estimated on the basis of three consecutive 24-hour urine samples completed before each visit, using urinary excretion of urea nitrogen.
GFR was measured by plasma clearance of 51Cr-EDTA over a 4 hour period and standardized for 1.73m2 body surface area using the same surface for each patient during the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low protein diet
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.
Normal protein diet
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* duration at least 10 years
* onset before age of 35,
* presence of diabetic retinopathy
* albuminuria\>=300mg/24 h in at least 2/3 sterile urine samples
* no clinical or laboratory evidence of other kidney or urinary tract disease
* GFR above 20mL/min/1.73M2
* pre-study decline in GFR\>= 2 mL/min/year
Exclusion Criteria
* history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months
18 Years
60 Years
ALL
No
Sponsors
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Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Peter Rossing
Chief physician and Director of Research
Principal Investigators
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Henrik P Hansen, MD
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center
Gentofte Municipality, Gentofte, Denmark
Countries
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Other Identifiers
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Low Protein Diet
Identifier Type: -
Identifier Source: org_study_id