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

Launched by STENO DIABETES CENTER COPENHAGEN · Jan 30, 2012

Keywords

ClinConnect Summary

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 GFR) assigned to receive either a usual-protein diet or a low-protein diet.

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • pregnancy
• • history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months

Trial Officials