Status:
COMPLETED
Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Type 1 Diabetes Mellitus With Diabetic Nephropathy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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.
Detailed Description
The study was a prospective, randomized, unmasked, controlled trial carried out at the Steno Diabetes Center. With concealed randomization the patients were (in blocks of two according to the level of...
Eligibility Criteria
Inclusion
- Diabetes mellitus type 1
- 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
- pregnancy
- history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months
Key Trial Info
Start Date :
April 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2000
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01521910
Start Date
April 1 1995
End Date
June 1 2000
Last Update
January 31 2012
Active Locations (1)
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1
Steno Diabetes Center
Gentofte Municipality, Gentofte, Denmark, 2820