Trial reportDiabetologia2009
Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy: a randomised controlled trial.
Trial report in Diabetologia, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00448526 (Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy), which is not on this map. Cited by 33 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
Who cites it
33 citing papers in PubMed, 6 syntheses or guidelines pooled it, 81 citations in OpenAlex.
- Protein restriction for diabetic kidney disease.The Cochrane database of systematic reviews · 2023Pooled it
- The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019).Hypertension research : official journal of the Japanese Society of Hypertension · 2019Guideline
- Efficacy of low-protein diet in diabetic nephropathy: a meta-analysis of randomized controlled trials.Lipids in health and disease · 2019Pooled it
- Efficacy of low-protein diet for diabetic nephropathy: a systematic review of randomized controlled trials.Lipids in health and disease · 2018Pooled it
- Effect of diet protein restriction on progression of chronic kidney disease: A systematic review and meta-analysis.PloS one · 2018Pooled it
- Pooled it
- Efficacy of Low-Protein Rice for Dietary Protein Restriction in CKD Patients: A Multicenter, Randomized, Controlled Study.Kidney360 · 2022Trial
- Asian Pacific Society of Nephrology Clinical Practice Guideline on Diabetic Kidney Disease-2025 Update.Nephrology (Carlton, Vic.) · 2025Article
- Low Protein Diet Reduces Proteinuria and Decline in Glomerular Filtration Rate in Advanced, Heavy Proteinuric Diabetic Kidney Disease.Nutrients · 2024Article
- Framework of Guidelines for Management of CKD in Asia.Kidney international reports · 2024Article
- Dysregulation of miR-638 in diabetic nephropathy and its role in inflammatory response.Diabetology & metabolic syndrome · 2021Article
- Diabetic Kidney Disease Benefits from Intensive Low-Protein Diet: Updated Systematic Review and Meta-analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021Review
- Mitochondrial Dysfunction and Diabetic Nephropathy: Nontraditional Therapeutic Opportunities.Journal of diabetes research · 2021Review
- Sarcopenia during COVID-19 lockdown restrictions: long-term health effects of short-term muscle loss.GeroScience · 2020Review
- Medical nutrition therapy and dietary counseling for patients with diabetes-energy, carbohydrates, protein intake and dietary counseling.Diabetology international · 2020Article
- Effects of dietary protein intake on renal outcome and mortality in patients with advanced diabetic nephropathy.Clinical and experimental nephrology · 2020Observational
- Article
- miRNA-214 suppresses oxidative stress in diabetic nephropathy via the ROS/Akt/mTOR signaling pathway and uncoupling protein 2.Experimental and therapeutic medicine · 2019Article
- A Low-Protein Diet for Diabetic Kidney Disease: Its Effect and Molecular Mechanism, an Approach from Animal Studies.Nutrients · 2018Review
- Japanese Clinical Practice Guideline for Diabetes 2016.Journal of diabetes investigation · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aims/hypothesisThere 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.
methodsThis 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(-1) day(-1)) and normal-protein diet (1.2 g kg(-1) day(-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.
resultsThe 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/
interpretationIt 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. CLINICAL
trial registrationClinicalTrials.gov NCT00448526.
fundingResearch grant from the Ministry of Health, Labour and Welfare of Japan.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.