title: Effect of low-protein diet on kidney function in diabetic nephropathy: meta-analysis of randomised controlled trials.
abstract: OBJECTIVE
  To evaluate the effect of low-protein diet on kidney function in patients with diabetic nephropathy.
  
  
  METHODS
  A systematic review and a meta-analysis of randomised controlled trials.
  
  
  METHODS
  MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, International Standard Randomised Controlled Trial Number (ISRCTN) Register and University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) from inception to 10 December 2012. Internet searches were also carried out with general search engines (Google and Google Scholar).
  
  
  METHODS
  Randomised controlled trials that compared low-protein diet versus control diet and assessed the effects on kidney function, proteinuria, glycaemic control or nutritional status.
  The primary outcome was a change in the glomerular filtration rate (GFR). The secondary outcomes were changes in proteinuria, post-treatment value of glycated haemoglobin A1C (HbA1c) and post-treatment value of serum albumin. The results were summarised as the mean difference for continuous outcomes and pooled by the random effects model. Subgroup analyses and sensitivity analyses were conducted regarding patient characteristics, intervention period, methodological quality and assessment of diet compliance. The assessment of diet compliance was performed based on the actual protein intake ratio (APIR) of the low-protein diet group to the control group.
  
  
  RESULTS
  We identified 13 randomised controlled trials enrolling 779 patients. A low-protein diet was associated with a significant improvement in GFR (5.82 ml/min/1.73 m(2), 95% CI 2.30 to 9.33, I(2)=92%; n=624). This effect was consistent across the subgroups of type of diabetes, stages of nephropathy and intervention period. However, GFR was improved only when diet compliance was fair (8.92, 95% CI 2.75 to 15.09, I(2)=92% for APIR <0.9 and 0.03, 95% CI -1.49 to 1.56, I(2)=90% for APIR ≥0.9). Proteinuria and serum albumin were not differed between the groups. HbA1c was slightly but significantly decreased in the low-protein diet group (-0.26%, 95% CI -0.35 to -0.18, I(2)=0%; n=536).
  
  
  CONCLUSIONS
  Low-protein diet was significantly associated with improvement of diabetic nephropathy. The adverse effects of low-protein diet were not apparent such as worsening of glycaemic control and malnutrition.
authors.affiliation: Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus, Okinawa, Japan.
authors.forename: Uru
authors.initials: U
authors.lastname: Nezu
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kamiyama
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Kondo
authors.forename: Mio
authors.initials: M
authors.lastname: Sakuma
authors.forename: Takeshi
authors.initials: T
authors.lastname: Morimoto
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Ueda