Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy: A randomised controlled trial

D. Koya, M. Haneda, S. Inomata, Y. Suzuki, D. Suzuki, Hirofumi Makino, Kenichi Shikata, Y. Murakami, Y. Tomino, K. Yamada, S. I. Araki, A. Kashiwagi, R. Kikkawa

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Abstract

Aims/hypothesis: There is currently insufficient evidence to recommend a low-protein diet for type 2 diabetic patients with diabetic nephropathy. We assessed whether a low-protein diet could prevent the progression of diabetic nephropathy. Methods: This was a multi-site parallel randomised controlled trial for prevention of diabetic nephropathy progression among 112 Japanese type 2 diabetic patients with overt nephropathy. It was conducted in Japan from 1 December 1997 to 30 April 2006. The participants were randomly assigned using a central computer-generated schedule to either low-protein diet (0.8 g kg -1day-1) and normal-protein diet (1.2 g kg -1day-1), and were followed for 5 years. The participants and investigators were not blinded to the assignment. The primary outcomes were the annual change in estimated GFR and creatinine clearance, the incidence of doubling of serum creatinine and the time to doubling of baseline serum creatinine. Results: The study was completed by 47 (84%) of 56 participants in the low-protein diet group and 41 (73%) of 56 participants in the normal-diet group. During the study period, the difference in mean annual change in estimated GFR between the low-protein diet and the normal-protein diet groups was -0.3 ml min-1 1.73 m-2 (95% CI -3.9, 4.4; p=0.93). The difference in mean annual change in creatinine clearance between the low-protein diet and the normal-protein diet groups was -0.006 ml s-1 1.73 m-2 (95% CI -0.089, 0.112; p=0.80). A doubling of serum creatinine was reached in 16 patients of the low-protein group (34.0%), compared with 15 in the normal-protein group (36.6%), the difference between groups being -2.6% (95% CI -22.6, 17.5; p=0.80). The time to doubling of serum creatinine was similar in both groups (p=0.66). Conclusions/interpretation: It is extremely difficult to get patients to follow a long-term low-protein diet. Although in the low-protein group overall protein intake was slightly (but not significantly) lower, it did not confer renoprotection.

Original languageEnglish
Pages (from-to)2037-2045
Number of pages9
JournalDiabetologia
Volume52
Issue number10
DOIs
Publication statusPublished - Oct 2009

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Protein-Restricted Diet
Dietary Proteins
Diabetic Nephropathies
Randomized Controlled Trials
Creatinine
Proteins
Diet
Serum
Appointments and Schedules
Japan
Research Personnel
Incidence

Keywords

  • Albuminuria
  • Diabetic nephropathy
  • EGFR
  • Low-protein diet
  • Proteinuria

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy : A randomised controlled trial. / Koya, D.; Haneda, M.; Inomata, S.; Suzuki, Y.; Suzuki, D.; Makino, Hirofumi; Shikata, Kenichi; Murakami, Y.; Tomino, Y.; Yamada, K.; Araki, S. I.; Kashiwagi, A.; Kikkawa, R.

In: Diabetologia, Vol. 52, No. 10, 10.2009, p. 2037-2045.

Research output: Contribution to journalArticle

Koya, D, Haneda, M, Inomata, S, Suzuki, Y, Suzuki, D, Makino, H, Shikata, K, Murakami, Y, Tomino, Y, Yamada, K, Araki, SI, Kashiwagi, A & Kikkawa, R 2009, 'Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy: A randomised controlled trial', Diabetologia, vol. 52, no. 10, pp. 2037-2045. https://doi.org/10.1007/s00125-009-1467-8
Koya, D. ; Haneda, M. ; Inomata, S. ; Suzuki, Y. ; Suzuki, D. ; Makino, Hirofumi ; Shikata, Kenichi ; Murakami, Y. ; Tomino, Y. ; Yamada, K. ; Araki, S. I. ; Kashiwagi, A. ; Kikkawa, R. / Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy : A randomised controlled trial. In: Diabetologia. 2009 ; Vol. 52, No. 10. pp. 2037-2045.
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abstract = "Aims/hypothesis: There is currently insufficient evidence to recommend a low-protein diet for type 2 diabetic patients with diabetic nephropathy. We assessed whether a low-protein diet could prevent the progression of diabetic nephropathy. Methods: This was a multi-site parallel randomised controlled trial for prevention of diabetic nephropathy progression among 112 Japanese type 2 diabetic patients with overt nephropathy. It was conducted in Japan from 1 December 1997 to 30 April 2006. The participants were randomly assigned using a central computer-generated schedule to either low-protein diet (0.8 g kg -1day-1) and normal-protein diet (1.2 g kg -1day-1), and were followed for 5 years. The participants and investigators were not blinded to the assignment. The primary outcomes were the annual change in estimated GFR and creatinine clearance, the incidence of doubling of serum creatinine and the time to doubling of baseline serum creatinine. Results: The study was completed by 47 (84{\%}) of 56 participants in the low-protein diet group and 41 (73{\%}) of 56 participants in the normal-diet group. During the study period, the difference in mean annual change in estimated GFR between the low-protein diet and the normal-protein diet groups was -0.3 ml min-1 1.73 m-2 (95{\%} CI -3.9, 4.4; p=0.93). The difference in mean annual change in creatinine clearance between the low-protein diet and the normal-protein diet groups was -0.006 ml s-1 1.73 m-2 (95{\%} CI -0.089, 0.112; p=0.80). A doubling of serum creatinine was reached in 16 patients of the low-protein group (34.0{\%}), compared with 15 in the normal-protein group (36.6{\%}), the difference between groups being -2.6{\%} (95{\%} CI -22.6, 17.5; p=0.80). The time to doubling of serum creatinine was similar in both groups (p=0.66). Conclusions/interpretation: It is extremely difficult to get patients to follow a long-term low-protein diet. Although in the low-protein group overall protein intake was slightly (but not significantly) lower, it did not confer renoprotection.",
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author = "D. Koya and M. Haneda and S. Inomata and Y. Suzuki and D. Suzuki and Hirofumi Makino and Kenichi Shikata and Y. Murakami and Y. Tomino and K. Yamada and Araki, {S. I.} and A. Kashiwagi and R. Kikkawa",
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AU - Koya, D.

AU - Haneda, M.

AU - Inomata, S.

AU - Suzuki, Y.

AU - Suzuki, D.

AU - Makino, Hirofumi

AU - Shikata, Kenichi

AU - Murakami, Y.

AU - Tomino, Y.

AU - Yamada, K.

AU - Araki, S. I.

AU - Kashiwagi, A.

AU - Kikkawa, R.

PY - 2009/10

Y1 - 2009/10

N2 - Aims/hypothesis: There is currently insufficient evidence to recommend a low-protein diet for type 2 diabetic patients with diabetic nephropathy. We assessed whether a low-protein diet could prevent the progression of diabetic nephropathy. Methods: This was a multi-site parallel randomised controlled trial for prevention of diabetic nephropathy progression among 112 Japanese type 2 diabetic patients with overt nephropathy. It was conducted in Japan from 1 December 1997 to 30 April 2006. The participants were randomly assigned using a central computer-generated schedule to either low-protein diet (0.8 g kg -1day-1) and normal-protein diet (1.2 g kg -1day-1), and were followed for 5 years. The participants and investigators were not blinded to the assignment. The primary outcomes were the annual change in estimated GFR and creatinine clearance, the incidence of doubling of serum creatinine and the time to doubling of baseline serum creatinine. Results: The study was completed by 47 (84%) of 56 participants in the low-protein diet group and 41 (73%) of 56 participants in the normal-diet group. During the study period, the difference in mean annual change in estimated GFR between the low-protein diet and the normal-protein diet groups was -0.3 ml min-1 1.73 m-2 (95% CI -3.9, 4.4; p=0.93). The difference in mean annual change in creatinine clearance between the low-protein diet and the normal-protein diet groups was -0.006 ml s-1 1.73 m-2 (95% CI -0.089, 0.112; p=0.80). A doubling of serum creatinine was reached in 16 patients of the low-protein group (34.0%), compared with 15 in the normal-protein group (36.6%), the difference between groups being -2.6% (95% CI -22.6, 17.5; p=0.80). The time to doubling of serum creatinine was similar in both groups (p=0.66). Conclusions/interpretation: It is extremely difficult to get patients to follow a long-term low-protein diet. Although in the low-protein group overall protein intake was slightly (but not significantly) lower, it did not confer renoprotection.

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KW - Albuminuria

KW - Diabetic nephropathy

KW - EGFR

KW - Low-protein diet

KW - Proteinuria

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