OBJECTIVE: To evaluate whether restricting protein intake may delay the progression of chronic renal failure caused by overt diabetic nephropathy and also whether this increases the risk of malnutrition. DESIGN: Prospective clinical trial. SETTING:Nephrology outpatients. PATIENTS: Sixty-nine patients (32 affected by type 1 and 37 by type 2 diabetes, all treated with insulin) affected by both overt diabetic nephropathy and hypertension. INTERVENTION: The study was started once hypertension and glycemia had been under control for at least 3 months. Two groups of patients, matched for similar mean glomerular filtration rate value and nutritional status, were studied: a low-protein diet (0.6 g/kg/d) was randomly prescribed to 35 patients, whereas in the other 34 patients a free diet intake was maintained for 12 months. MAIN OUTCOME MEASURE: Renal function and nutritional status. RESULTS: The protein intake was significantly different in the 2 groups of patients, whereas the average decline of glomerular filtration rate during the follow-up was comparable. In the low-protein diet group, serum prealbumin concentration significantly decreased after 9 months, whereas serum albumin decreased at the end of the study. CONCLUSION:Severe dietary protein restriction does not seem to delay the progression of renal disease in patients with overt diabetic nephropathy, whereas it may induce malnutrition. Copyright 2002 by the National Kidney Foundation, Inc.
RCT Entities:
OBJECTIVE: To evaluate whether restricting protein intake may delay the progression of chronic renal failure caused by overt diabetic nephropathy and also whether this increases the risk of malnutrition. DESIGN: Prospective clinical trial. SETTING: Nephrology outpatients. PATIENTS: Sixty-nine patients (32 affected by type 1 and 37 by type 2 diabetes, all treated with insulin) affected by both overt diabetic nephropathy and hypertension. INTERVENTION: The study was started once hypertension and glycemia had been under control for at least 3 months. Two groups of patients, matched for similar mean glomerular filtration rate value and nutritional status, were studied: a low-protein diet (0.6 g/kg/d) was randomly prescribed to 35 patients, whereas in the other 34 patients a free diet intake was maintained for 12 months. MAIN OUTCOME MEASURE: Renal function and nutritional status. RESULTS: The protein intake was significantly different in the 2 groups of patients, whereas the average decline of glomerular filtration rate during the follow-up was comparable. In the low-protein diet group, serum prealbumin concentration significantly decreased after 9 months, whereas serum albumin decreased at the end of the study. CONCLUSION: Severe dietary protein restriction does not seem to delay the progression of renal disease in patients with overt diabetic nephropathy, whereas it may induce malnutrition. Copyright 2002 by the National Kidney Foundation, Inc.