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Restricción proteica para la nefropatía diabética

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Referencias

Referencias de los estudios incluidos en esta revisión

Barsotti 1988 {published data only}

Barsotti G, Ciardella F, Morelli E, Cupisti A, Mantovanelli A, Giovannetti S. Nutritional treatment of renal failure in type 1 diabetic nephropathy. Clinical Nephrology 1988;29:280‐287.
Barsotti G, Navalesi R, Giampietro O, Cioardella F, Morelli E, Cupisti A, Mantovanelli A, Giovanetti S. Effects of a vegetarian, supplemented diet on renal function, proteinuria and glucose metabolism in patients with 'overt' diabetic nephropathy and renal insufficency. Contributions to Nephrology 1988;65:87‐94.

Barsotti 1998 {published data only}

Barsotti G, Cupisti A, Barsotti M, Sposini S, Palmieri D, Meola M, Lenti C, Morelli E. Dietary treatment of diabetic nephropathy with chronic renal failure. Nephrology Dialysis Transplantation 1998;13 (Suppl 8):49‐52.

Brouhard 1990 {published data only}

Brouhard BH, LaGrone L. Effect of dietary protein restriction on renal function reserve in diabetic nephropathy. The American Journal of Medicine 1990;89:427‐31.

Ciavarella 1987 {published data only}

Ciavarella A, Gianfranco MI, Stefoni S, Borgnino LC, Bannini P. Reduced albuminuria after dietary protein restrictions in insulin dependent diabetic patients with clinical nephropathy. Diabetes Care 1987;10:407‐13.

Dullart 1993 {published data only}

Dullart RP, Beusenkamp BJ, Meijer S, van Doormaal JJ, Sluiter WJ. Long term effects of protein‐restricted diet on albuminuria and renal function in IDDM patients without clinical nephropathy and hypertension. Diabetes Care 1993;16:483‐92.

Hansen 2002 {published data only}

Hansen HP, Tauber‐Lassen E, Jensen BR, Parving H‐H. Effect of dietary protein restriction on prognosis in patients with diabetic nephropathy. Kidney International 2002;62:220‐228.

Meloni 2002 {published data only}

Meloni C, Morosetti M, Suraci C, Pennafina MG, Tozzo C, Taccone‐Gallucci M, Casciani CU. Severe dietary protein restriction in overt diabetic nephropathy: benefits or risks?. Journal of Renal Nutrition 2002;12:96‐101.

Meloni 2004 {published data only}

Meloni C, Tatangelo P, Cipriani S, Rossi V, Suraci C, Tozzo C, Rossini B, Cecilia A, Di Franco D, Straccialano E, Casciani CU. Adequate protein dietary restriction in diabetic and nondiabetic patients with chronic renal failure. Journal of Renal Nutrition 2004;14:208‐13.

Pijls 2002 {published data only}

Pijls LTJ, de Vries H, Donker AJM, Van Eijk T. The effect of protein restriction on albuminuria in patients with type 2 diabetes mellitus: a randomized trial. Nephrology Dialysis Transplantation 1999;14:1445‐1453.
Pijls LTJ, de Vries H, van Eijk JT, Donker AJM. Protein restriction, glomerular filtration rate and albuminuria in patients with type 2 diabetes mellitus: A randomized trial. European Journal of Clinical Nutrition 2002;56:1200‐1207.

Raal 1994 {published data only}

Raal FJ, Kalk WJ, Lawson M, Esser JD, Buys R, Fourie L. Effect of moderate dietary protein restriction on the progression of overt diabetic nephropathy: a 6‐month prospective study. American Journal of Clinical Nutrition 1994;60:579‐85.

Walker 1989 {published data only}

Walker JF, Bending JJ, Dodds RA, Mattock MB, Murrells TJ, Keen H. Restriction of dietary protein and progression of renal failure in diabetic nephropathy. Lancet 1989;December:1411‐5.

Zeller 1991 {published data only}

Zeller K, Whittaker E, Sullivan L, Raskin P, Jacobson HR. Effect of restricting dietary protein on the progression of renal failure in patients with insulin‐dependent diabetes mellitus. New England Journal of Medicine 1991;324:78‐84.

Referencias de los estudios excluidos de esta revisión

Attman 1983 {published data only}

Attman PO, Bucht H, Larsson O, Uddebom G. Protein restricted diet in diabetic renal failure. Clinical Nephrology 1983;19:217‐20.

Azadbakht 2003 {published data only}

Azadbakht L, Shakerhosseini R, Atabak S, Jamshidian M, Mehrabi Y, Esmaill‐Zadeh A. Beneficiary effect of dietary soy protein on lowering plasma levels of lipid and improving kidney function in type II diabetes with nephropathy. European Journal of Clinical Nutrition 2003;57:1292‐4.

Bending 1988 {published data only}

Bending JJ, Dodds RA, Keen H, Viberti G. Renal response to restricted protein intake in diabetic nephropathy. Diabetes 1988;27:1641‐6.

Brodsky 1992 {published data only}

Brodsky IG, Robbins DC, Hiser E, Fuller SP, Fillyaw M, Devlin JT. Effects of low protein diets on protein metabolism in insulin‐dependent diabetes mellitus patients with early nephropathy. Journal of Clinical Endocrinologgy Metabolism 1992;75:351‐7.

Brouhard 1986 {published data only}

Brouhard BH, LaGrone LF, Richards GE, Travis LB. Short‐term protein loading in diabetics with a ten‐year duration of disease. American Journal of Disease in Childhood 1986;140:473‐6.

Cianciaruso 1989 {published data only}

Cianciaruso B, Capuano A, D' Amaro E, Ferrara N, Nastasi A, Conte G, Bellizzi V, Andreucci VE. Dietary compliance to a low protein and phosphate diet in patients with chronic renal failure. Kidney International 1989;36:173‐6.

Cohen 1987 {published data only}

Cohen D, Dodds R, Viberti G. Effect of protein restriction in insulin dependent diabetics at risk of nephropathy. British Medical Journal 1987;294:795‐8.

Evanoff 1989 {published data only}

Evanoff G, Thompson C, Brown J, Weinman E. Prolonged dietary protein restriction in diabetic nephrology. Archives of Internal Medicine 1989;149:1129‐33.
Evanoff GV, Thompson CS, Brown J, Weinman EJ. The Effect of Dietary Protein Restriction on the progression of Diabetic Nephropathy. Archives of Internal Medicine 1987;147:492‐495.

Facchini 2003 {published data only}

Facchini FS, Saylor KL. A low‐iron‐available, polyphenol‐enriched, carbohydrate‐restricted diet to slow progression of diabetic nephropathy.. Diabetes 2003;52:1204‐9.

Gin 1991 {published data only}

Gin H, Aparicio M, Potaux L, Merville P, Combe Ch, de Precigout V, Bouchet J‐L, Aubertin J. Low ‐protein, low‐phosphorous diet and tissue insulin sensitivity in insulin‐dependent diabetic patients with chronic renal failure. Nephron 1991;57:411‐5.

Gross 2002 {published data only}

Gross JL, Zelmanovitz T, Moulin CC, De M, V, Perassolo M, Leitao C, Hoefel A, Paggi A, Azevedo MJ. Effect of a chicken‐based diet on renal function and lipid profile in patients with type 2 diabetes: a randomized crossover trial. Diabetes Care 2002;25:645‐51.

Hansen 1999 {published data only}

Hansen HP, Christensen PK, Tauber‐Lassen E, Klausen A, Jensen BR, Parving H‐H. Low‐protein diet and kidney function in insulin‐dependent diabetic patients with diabetic nephropathy. Kidney International 1999;55:621‐628.

Jibani 1991 {published data only}

Jibani MM, Bloodworth LL, Foden E, Griffiths KD, Galpin OP. Predominantly vegetarian diet in patinets with incipient and early clinical diabetic nephropathy: effects on albumin excretion rate and nutritional status. Diabetic Medicine 1991;8:949‐53.

Kupin 1987 {published data only}

Kupin WL, Cortes P, Dumler F, Feldkamp CS, Kilates MC, Levin NW. Effect on renal function of change from high to moderate protein intake in type 1 diabetic patients. Diabetes 1987;36:73‐9.

Levine 1989 {published data only}

Levine SE, S'Elia JA, Bistrian B, Smith‐Ossman S, Gleason R, Mitche WE, Miller GG. Protein restricted diets in diabetic nephropathy. Nephron 1989;52:55‐61.

Mollsten 2001 {published data only}

Mollsten AV, Dahlquist GG, Stattin EL, Rudberg S. Higher intakes of fish protein are related to a lower risk of microalbuminuria in young Swedish type 1 diabetic patients. Diabetes Care 2001;24:805‐10.

Parillo 1988 {published data only}

Parrilo M, Riccardi G, Pacioni D, Iovine C, Contaldo F, Isernia C, Marco F, Perrotti N, Rivellese A. Metabolic consequences of feeding a high carbohydrate, high fibre diet to diabetic patients with chronic kidney failure. American Journal of Clinical Nutrition 1988;48:255‐9.

Pecis 1994 {published data only}

Pecis M, de Azevedo MJ, Gross JL. Chicken and fish diet reduced glomerular hyperfiltration in IDDM patients. Diabetes Care 1994;17:665‐72.

Pedersen 1989 {published data only}

Pedersen M, Mogensen CE, Schonau JF, Moller B, Lykke G, Pedersen O. Renal effects from limitation of high dietary protein in normoallbuminuric diabetic patients. Kidney International 1989;36:115‐21.

Rudberg 1988 {published data only}

Rudberg S, Dahlquist G, Aperia A, Persson B. Reduction of protein intake decreases glomerular filtration rate in young Type 1 (insulin‐dependent) diabetic patients mainly in hyperfiltering patients. Diabetologia 1988;31:878‐83.

Stephenson 2005 {published data only}

Stephenson TJ, Setchell KD, Kendall CW, Jenkins DJ, Anderson JW, Fanti P. Effect of soy protein‐rich diet on renal function in young adults with insulin‐dependent diabetes mellitus. Clinical Nephrology 2005;64:1‐11.

Stojceva‐Taneva 2001 {published data only}

Stojceva‐Taneva O, Polenakovic M, Grozdanovski R, Sikole A. Lipids, protein intake, and progression of diabetic nephropathy. Nephrology Dialysis Transplantation 2001;16 (Suppl. 6):90‐91.

Wheeler 2002 {published data only}

Wheeler ML, Fineberg SE, Fineberg NS, Gibson RG, Hackward LL. Animal versus plant protein meals in individuals with type 2 diabetes and microalbuminuria: effects on renal, glycemic, and lipid parameters.[see comment]. Diabetes Care 2002;25:1277‐82.

Wiseman 1987 {published data only}

Wiseman MJ, Bognetti E, Dodds R, Keen H, Viberti G. Changes in renal function in response to protein restricted diet in type 1 (insulin‐dependent) diabetic patients. Diabetologia 1987;30:154‐5.

Referencias adicionales

Bilous 2005

Bilous RW. The kidney in systemic disease. In: Warrell DA, Cox TM, Firth JD, Benz EJ editor(s). Oxford Textbook of Medicine. 4th Edition. Vol. 3, Oxford: Oxford University Press, 2005.

Brenner 1982

Brenner BM, Meyer TW, Hostetter TH. Dietary protein intake and the progressive nature of kidney disease. New England Journal of Medicine 1982;307:652‐9.

Connor 2003

Connor H, Annan F, Bunn E, Frost G, McGough N, Sarwar T, Thomas B. The implementation of nutritional advice for people with diabetes. Diabetic Medicine 2003;20:786‐807.

El Nahas 1984

El Nahas AM, Masters‐Thomas A, Brady SA. Selective effect of low protein diets in chronic renal diseases. British Medical Journal 1984;289:1337‐41.

Finne 2005

Finne P, Reunanen A, Stenman S, Groop PH, Gronhagen‐Riska C. Incidence of end‐stage renal disease in patients with type 1 diabetes. JAMA 2005;295:1782‐1787.

Gross 2005

Gross JL, de Azevedo MJ, Silveiro SP, Canani LH, Caramori ML, Zelmanovitz T. Diabetic Nephropathy: Diagnosis, Prevention, and Treatment. Diabetes Care 2005;28:164‐176.

Higgins 2002

Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta‐analysis. Statistics in medicine 2002;21:1539‐58.

Higgins 2003

Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analysis. BMJ 2003;327:557‐60.

Ikizler 1995

Ikizler TA, Greene JH, Wingard RL. Spontaneous dietary protein intake during progression of chronic renal failure. Journal of the American Society of Nephrology 1995;6:1386‐1391.

Jadad 1996

Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary?. Controlled Clinical Trials 1996;17:1‐12.

Klahr 1994

Klahr S, Levey AS, Beck GJ. The effects of dietary protein restriction and blood pressure control on the progression of chronic renal diseases. New England Journal of Medicine 1994;330:884.

Levey 1994

Levey AS, Beck GJ, Caggiula AW. Trends towards a beneficial effect of a low protein diet during additional follow‐up in the Modification of Diet in Renal Disease Study. Journal of the American Society of Nephrology 1994;5:336A.

Maschio 1982

Maschio G, Oldrizzi L, Tessitore N, D'Angelo A, Valvo E, Lupo A, et al. Effects of dietary protein and phosphorus restriction on the progression of early renal failure. Kidney International 1982;22:371‐6.

MDRD Study Grp 1989

Modification of Diet in Renal Disease (MDRD) Study Group. Nutritional status of patients with different levels of chronic renal insufficiency. Kidney International 1989;36(Supp 27):S184‐94.

Mogensen 1976

Mogensen CE. Progression of nephropathy in long‐term diabetes with proteinuria and effect of initial anti‐hypertensive therapy. Scandinavian Journal of Clinical Investigations 1976;36:383‐8.

Parving 1981

Parving H‐H, Smidt UM, Friisberg B, Bonnevie‐Nielsen V, Andersen AR. A prospective study of glomerular filtration rate and arterial blood pressure in insulin‐dependent diabetics with diabetic nephropathy. Diabetologia 1981;20:457‐461.

Pedrini 1996

Pedrini MT, Levey AS, Lau J, Chalmers TC, Wang PH. The Effect of Dietary Protein Restriction on the Progression of Diabetic and Nondiabetic Renal diseases: A Meta‐analysis. Annals of Internal Medicine 1996;124(7):627‐632.

Raine 1995

Raine AEG. The rising tide of diabetic nephropathy ‐ the warning before the flood?. Nephrology Dialysis and Transplantation 1995;10:460‐1.

Rosman 1984

Rosman JB, Meijer S, Sluiter WJ, Wee PMT, Piers‐Becht TPM, Donker AJM. Prospective randomised trial of early protein restriction in chronic renal failure. Lancet 1984;December:1291‐6.

Schulz 1995

Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408‐12.

Sitprija 1983

Sitprija V, Suvanpha R. Low protein diet and chronic renal failure in Buddist monks. British Medical Journal 1983;287:469‐71.

Sterne 2001

Sterne JAC, Egger M, Davey Smith G. Investigating and dealing with publication and other biases. In: Egger M, Davey Smith G, Altman DG editor(s). Systematic Reviews in Health Care; Meta‐analysis in Context. London: BMJ Publishing Group, 2001:189‐208.

Toeller 1996

Toeller M, Klischan A, Heitkamp G, Schumacher W, Milne R, Buyken A, Karamanos B, Gries FA. Nutrutional intake of 2868 IDDM patients from 30 centres in Europe. Diabetologia 1996;39:929‐939.

Viberti 1983

Viberti GC, Bilous RW, Mackintosh D, Keen H. Monitoring Glomerular Function in Diabetic Nephropathy. The American Journal of Medicine 1983;74:256‐64.

Waugh 2003

Waugh N, Robertson A. Treatment of diabetic nephropathy: low protein diet. Management of Diabetic Nephropathy. London: Martin Dunitz Ltd, 2003.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Barsotti 1988

Methods

Before and after study.
Mean duration on UPD 15.9 months. Mean duration on LPD 17.4 months.

Participants

8 type 1 patients with severe renal failure.
Mean age 44.7.
Mean duration of diabetes 20.5 years.

Interventions

LPD was a low protein vegetarian diet. Low phosphorous. Supplemented with EAA and ketoanalogs. 4 patients were permitted to eat normal wheat flour products. 4 used protein‐free substitutes.
UPD = 1.2‐1.4 g/kg/day.

Outcomes

Creatinine clearance.
Nutritional status assessed by TST & MAMC, serum albumin, serum transferrin and serum complement.
Compliance assessed by urinary urea. Actual protein intake in LPD not reported.

Notes

4 out of the 8 patients changed to maintenance hemodialysis after a period of 11 to 29 months. In 2 patients there was a spontaneous decision to abandon the LPD due to compliance difficulties. In 2, dialysis was started as they were not responding to diuretic therapy.
No sign of protein or caloric malnutrition.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used

Barsotti 1998

Methods

Before and after study.
Mean duration 3.7 years.

Participants

22 type 1 and 10 type 2 patients with overt diabetic nephropathy.
Mean age 44.
Duration of diabetes not stated.

Interventions

UPD = Free diet.
LPD:
Diet A (n=19) 0.3 g/kg/day (patients with creatinine clearance ranging from 19 to 6.5 ml/min)
Diet B (n=13) 0.7 g/kg/day (patients with creatinine clearance ranging from 60 to 22 ml/min)
Both diets vegetarian.

Outcomes

Creatinine clearance.
Malnutrition assessed by anthropometric indices (Wt, TST, MAMC).
Compliance assessed by urinary urea. Diet A 45% good, Diet B 69% good.

Notes

No evidence of malnutrition.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used

Brouhard 1990

Methods

RCT.
12 months duration.
A 3 month trial period to assess compliance.

Participants

15 type 1 patients with microalbuminuria 30 ug/min.
LPD mean age 36.
UPD mean age 30.
Mean duration of diabetes 19 years.

Interventions

LPD = 0.6 g/kg/day (n=8).
UPD = 1.0 g/kg/day (n=7).

Outcomes

GFR.
Compliance by uU. Actual protein intake 0.6 g/kg/day.

Notes

After trial period, 1 patient requested normal diet, reinstated. No significant differences in baseline measurements between groups but UPD had worse factors.
No mention of malnutrition.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Ciavarella 1987

Methods

RCT.
Mean duration 4.5 months.

Participants

16 type 1 patients with proteinuria > 0.5g/24 hours; creatinine < 1.9mg/dl.
Mean age 37.
Duration of diabetes 10‐30 years.

Interventions

LPD = 0.71 g/kg/day (n=7).
UPD = 1.44 g/kg/day (n=9).

Outcomes

Creatinine clearance. Compliance verified by dietary interview, blood nitrogen and urea nitrogen excretion. Actual protein intake 0.71 g/kg/day.

Notes

Small numbers. No information on number with follow‐up under 4.5 months.
No mention of malnutrition

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Dullart 1993

Methods

RCT.
Duration 2 years.

Participants

31 type 1 patients with microalbuminuria (10‐200 ug/min overnight).
UPD mean age 39
LPD mean age 43
Duration of diabetes > 5 years.

Interventions

LPD = 0.6 g/kg/day (n=14).
UPD = 1.09 g/kg/day (n=16).
Diet supplement with methionine if necessary.

Outcomes

GFR.
Compliance assessed by uU. Actual protein intake 0.79 g/kg/day.
Malnutrition assessed by calorie intake, BMI and serum albumin.

Notes

No evidence of malnutrition.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Hansen 2002

Methods

RCT.
Duration 4 years.

Participants

82 type 1 patients (18‐60 yrs) with diabetic retinopathy, albuminuria >= 300 mg/24 hr.
GFR above 20ml/min/1.73 m2 and a pre‐study decline in GFR >=2 ml/min/year (progressive diabetic nephropathy).
Mean duration of diabetes LPD 28 years, UPD 27 years.

Interventions

LPD = 0.6 g/kg/day. Supplementation of calcium of 500 mg/day (n=38).
UPD = patients' pre‐study diet (n=34).

Outcomes

GFR.
RR of ESRD or death.
Malnutrition assessed by mid‐arm circumference, serum albumin and body weight.
Compliance monitored by dietary interview and uU. Actual protein intake 0.89 g/kg/day.

Notes

Comparable number in both groups received antihypertensives and ACE but +4 at follow‐up on antihypertensive and +4 on ACE.
Malnutrition indicators comparable in 2 groups, but data not shown.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Meloni 2002

Methods

RCT.
Duration 12 months.

Participants

32 type 1 patients (14‐32 yrs), duration of diabetes 20.9 years.
37 type 2 patients (15‐34 yrs), duration of diabetes 24.9 years.
Overt nephropathy and hypertension.

Interventions

LPD = 0.6 g/kg/day (n=20).
UPD = 1.39 g/kg/day (n=17).

Outcomes

GFR.
Malnutrition measured by serum albumin, serum pre‐albumin and anthropometric parameters.
Compliance monitored by uU. Actual protein intake 0.68 g/kg/day.

Notes

Malnutrition noted in LPD.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Meloni 2004

Methods

RCT.
Duration 12 months.

Participants

24 type 1 patients (mean age 47), duration of diabetes 20.9 years.
56 type 2 patients (mean age 63), duration of diabetes 24.9 years.

Interventions

LPD = 0.8 g/kg/day (n=40).
UPD = 1.24 g/kg/day (n=40).

Outcomes

GFR.
Malnutrition measured by serum albumin and pre‐albumin.
Compliance assessed by uU. Actual protein intake 0.86 g/kg/day.

Notes

No sign of malnutrition.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Pijls 2002

Methods

RCT.
Duration 28 months.
Data for 12 months.

Participants

160 type 2 patients.
Duration >5yrs.
UPD mean age 65, duration of diabetes 7.2 years.
LPD mean age 63, duration of diabetes 6.7 years.

Interventions

LPD = 0.8 g/kg/day (n=63).
UPD = 1.14 g/kg/day (n=68).

Outcomes

Estimated GFR measured with cimetidine‐influenced creatinine clearance.
Compliance assessed by uU. Actual protein intake 1.1 g/kg/day.

Notes

No mention of malnutrition.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Raal 1994

Methods

RCT.
Mean duration 6 months.

Participants

26 type 1 patients.
UPD mean age 30 years.
LPD mean age 29 years.
Duration of diabetes >= 10 years.

Interventions

LPD = 0.8 g/kg/day (n=11).
UPD = 2 g/kg/day (n=11).

Outcomes

GFR was measured by Cr EDTA.
Malnutrition assessed by body weights, serum total protein, and serum albumin.
Compliance assessed by dietary history carried out by a dietitian and by measurement of 24 hour uU nitrogen excretion. Actual protein intake 0.87 g/kg/day.

Notes

Body weight, serum total protein, and serum albumin concentrations did not decrease in patients consuming the protein‐restricted diet.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Walker 1989

Methods

Before and after study.
Mean duration on UPD was 29 months.
Mean duration on LPD was 33 months.

Participants

19 type 1 patients with proteinuria and GFR>20ml/min.
Mean age 42 years.
Mean duration of diabetes 24 years.

Interventions

LPD = 40g/day, half and half animal and vegetable sources. Patients whose urinary protein excretion rate exceeded 3g/24h were allowed an additional 1.6g of dietary protein per extra gram of urinary protein.
UPD = patients' normal diet.

Outcomes

GFR was assessed by clearance of Cr‐labelled edetic acid.
Malnutrition assessed by MAMC and plasma albumin.
Compliance assessed by uU, dietary history and weighed food record. Actual protain intake 0.67 g/kg/day.

Notes

4 patients were started on ACE inhibitors while on LPD. Data on these patients have been excluded from the analysis.
LPD had no untoward nutritional effect.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used

Zeller 1991

Methods

RCT .
Mean duration 35 months , minimum 12 months.

Participants

47 type 1 patients with proteinuria over 500mg/24 hours , with diabetic retinopathy and no other cause of renal failure .
LPD mean age 33. Mean duration of diabetes 21 years.
UPD mean age 35. Mean duration of diabetes 22.4 years.

Interventions

LPD = 0.6g / kg / ideal body weight/day (n=20).
UPD = at least 1 g/kg/day (n=15).

Outcomes

GFR by iothalamate and creatinine.
Malnutrition measured by weight, mid‐arm circumference, and serum albumin.
Compliance assessed by uU and dietary history. Actual protein intake 0.72 g/kg/day.

Notes

Malnutrition measures showed no significant change.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

LPD: Low protein diet
UPD: Usual protein diet
EAA: Essential amino acids
TST: Triceps skinfold thickness
MAMC: Middle arm muscle circumference
GFR: Glomerular filtration rate
BMI: Body mass index
RR: Relative risk
ESRD: End‐stage renal disease
ACE: Angiotensin converting enzyme
RCT: Randomised controlled trial
Wt: Weight

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Attman 1983

Late (pre‐dialysis) intervention

Azadbakht 2003

Duration only 7 weeks

Bending 1988

Duration only 3 weeks

Brodsky 1992

Duration only 12 weeks

Brouhard 1986

Control group were non‐diabetic

Cianciaruso 1989

Trial to assess compliance to a low protein diet

Cohen 1987

Duration only 3 weeks

Evanoff 1989

Changes in antihypertensive therapy

Facchini 2003

Comparison diet not usual diet (carbohydrate‐restricted, low‐iron‐available, polyphenol‐enriched diet

Gin 1991

Aim was to assess the effect of the increase in carbohydrate on insulin sensitivity

Gross 2002

Duration only 4 weeks

Hansen 1999

Duration only 8 weeks

Jibani 1991

Duration only 8 weeks

Kupin 1987

Two consecutive dietary periods of one week

Levine 1989

No comparison period, duration only 15 weeks

Mollsten 2001

Case control study

Parillo 1988

Duration only 10 days

Pecis 1994

Duration only 3 weeks

Pedersen 1989

Duration only 4 weeks

Rudberg 1988

Duration only 10 days

Stephenson 2005

Duration only 8 weeks

Stojceva‐Taneva 2001

Observational study

Wheeler 2002

Duration only 6 weeks

Wiseman 1987

Duration only 3 weeks

Data and analyses

Open in table viewer
Comparison 1. Low protein diet versus usual diet

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in glomerular filtration rate (ml/min) Show forest plot

7

222

Mean Difference (IV, Random, 95% CI)

0.14 [‐0.06, 0.34]

Analysis 1.1

Comparison 1 Low protein diet versus usual diet, Outcome 1 Change in glomerular filtration rate (ml/min).

Comparison 1 Low protein diet versus usual diet, Outcome 1 Change in glomerular filtration rate (ml/min).

Comparison 1 Low protein diet versus usual diet, Outcome 1 Change in glomerular filtration rate (ml/min).
Figuras y tablas -
Analysis 1.1

Comparison 1 Low protein diet versus usual diet, Outcome 1 Change in glomerular filtration rate (ml/min).

Comparison 1. Low protein diet versus usual diet

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in glomerular filtration rate (ml/min) Show forest plot

7

222

Mean Difference (IV, Random, 95% CI)

0.14 [‐0.06, 0.34]

Figuras y tablas -
Comparison 1. Low protein diet versus usual diet