Low-Protein Diets in Diabetic Chronic Kidney Disease (CKD) Patients: Are They Feasible and Worth the Effort?
Abstract
:1. Introduction
2. Experimental Section
2.1. Study Setting, Patient Selection and Inclusion Criteria
2.2. Diets and Controls
2.3. Collected Data
2.4. Statistical Analysis
2.5. Ethical Issues
3. Results
3.1. Baseline Data
3.1.1. Main Outcomes: Patient Survival
3.1.2. Main Outcomes: Dialysis Start
4. Diabetes as CKD or Diabetes as Comorbidity
5. Compliance and Metabolic Balance
Diabetes | No Diabetes | p | |
---|---|---|---|
Diabetes vs. Diabetes | |||
n (Overall: 449) | 149 (33.18%) | 300 (66.82%) | - |
Continues n (%) | 59 (39.60%) | 166 (55.33%) | 0.002 |
Discontinued n (%) | 3 (2.01%) | 5 (1.66%) | 0.793 |
Transferred n (%) | 0 (0%) | 6 (2%) | 0.082 |
Lost To Follow-up n (%) | 3 (2.01%) | 2 (0.66%) | 0.200 |
On Dialysis n (%) | 32 (21.48%) | 70 (23.33%) | 0.658 |
Dead n (%) | 52 (34.90%) | 51 (17%) | 0.001 |
Mean Follow-up (Months) Mean ± SD | 25.80 ± 21.04 | 21.35 ± 20.41 | 0.321 |
6. Discussion
7. Conclusions
Acknowledgments
Author Contributions
Conflicts of Interest
References
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Qualitative Strategies | ||
---|---|---|
0.6 g/Kg/day with Protein-Free Food | 0.6 g/Kg/day Vegan Supplemented | 0.6–0.8 g/Kg/day Vegan not Supplemented |
The strategy is to replace bread and pasta or rice, and regular flour with protein-free products. No restriction regards vegetables; fruits may be limited in diabetic patients. Food of animal origin, including dairy products, can be used as “seasoning” for the pasta, or as part of the “main course” that has to be completed with vegetables. | The diet is based on plant-derived food (fruit, vegetables, sugars, starches such as pasta and bread, cous-cous, polenta and legumes) supplemented by a mixture of amino acids and ketoacids. Supplements allow choosing any preferred plant-derived food without needing to integrate grains and legumes at each meals. The supplements are calculated as 1 tablet per 8–10 kg of body weight, the difference depending on proteinuria and nutritional status. | The diet is strictly vegan and includes only foods of plant origin (fruit, vegetables, starches, legumes); they must be combined to allow a balanced intake of essential amino acids. In order to integrate the proteins, the role of thumb is to integrate during the day at least two sources of starches with two kinds of legumes, or at least one type of starch and legume at each meal. |
Other strategies, qualitative and quantitative: 0.6 g/Kg/day non-supplemented or 0.3 g/Kg/day vegan supplemented | ||
Traditional 0.6 diets are employed in patients who prefer to keep a wide variety of food in the diet, and weigh them. Such a diet is usually designed with the dietician and is based upon a series of “equivalences” in protein portions. At least 40% of the proteins should be of animal origin. | ||
Vegan supplemented very low-protein diet (0.3 g/kg/day): This is a combination of vegan supplemented and protein-free food: starches are substituted with protein-free food and supplement doses are doubled (1 for each 5 kg of BW). The quantity of legumes may have to be restricted to adhere to the 0.3 target. | ||
Wine and beer are allowed in moderate quantities. Natural fruit juices are allowed, taking care to avoid sweeteners, taste enhancers and preservatives. Other commercial beverages (sodas) should be avoided. | ||
1–3 unrestricted meals per week are allowed: i.e., without any qualitative or quantitative restrictions, unless required for other diseases (diabetes, celiac disease, food intolerances etc.). | ||
Qualitative and quantitative modifications may be suggested according to the results of the blood and urinary controls. |
Diabetic Patients | Non-Diabetic Patients | p (Diab-Non-Diab) | |
---|---|---|---|
N | 149 | 300 | - |
(33.18%) | (66.82%) | ||
Males (%) | 87 | 190 | 0.315 |
(58.39%) | (63.33%) | ||
BMI | 27.14 | 25.71 | 0.07 |
median (min–max) | (15.5–44.92) | (13.32–46.67) | |
IQR | 4.8 | 4.79 | |
Age | 70 | 70 | 0.467 |
median (min–max) | (19–92) | (23–97) | |
IQR | 13 | 22.5 | |
Age over 65 (%) | 78 | 118 | 0.006 |
(52.35%) | (39.33%) | ||
Age over 80 (%) | 23 | 66 | 0.141 |
(15.44%) | (22.00%) | ||
Charlson | 8 | 6 | 0.002 |
median (min–max) | (2–13) | (2–13) | |
IQR | 3 | 4 | |
Charlson ≥ 7 (%) | 122 | 124 | <0.001 |
(81.88%) | (41.33%) | ||
Charlson ≥ 10 (%) | 44 | 27 | <0.001 |
(29.53%) | (9.00%) | ||
Cardiopathy (%) | 63 | 145 | 0.171 |
(42.28%) | (48.33%) | ||
sCreatinine (mg/dL) | 2.78 | 2.8 | 0.436 |
median (min–max) | (0.90–6.80) | (0.55–16) | |
IQR | 1.47 | 1.88 | |
eGFR-EPI (mL/min) | 20 | 20 | 0.797 |
median (min–max) | (6.3–79.7) | (3–127.10) | |
IQR | 11.2 | 15.9 | |
GFR < 15 mL/min at enrolment n (%) | 35 | 90 | 0.147 |
(23.49%) | (30.00%) | ||
GFR < 10 mL/min at enrolment n (%) | 13 | 31 | 0.589 |
(8.72%) | (10.33%) | ||
Proteinuria (g/day) | 0.8 | 0.7 | 0.553 |
median (min–max) | (0.08–15.80) | (0.04–11) | |
IQR | 2.95 | 1.7 | |
Proteinuria ≥ 1 g/day (%) | 78 | 124 | 0.027 |
(52.35%) | (41.33%) | ||
Proteinuria ≥ 3 g/day (%) | 41 | 41 | 0.002 |
(27.52%) | (13.67%) |
Diabetic Patients | Vegan Suppl. | With Protein-Free Food | Other | All Cases | p among Groups |
---|---|---|---|---|---|
N (%) | 59 | 70 | 20 | 149 | - |
(39.60%) | (46.98%) | (13.43%) | (100%) | ||
Males (%) | 40 | 39 | 8 | 87 | 0.076 |
(67.80%) | (55.71%) | 40% | (58.39%) | ||
BMI | 27.11 | 27.26 | 27.15 | 27.14 | 0.95 |
median (min–max) | (18.49–42.03) | (17.45–44.92) | (20.31–36.32) | (15.5–44.92) | |
IQR | 4.07 | 4.89 | 7.65 | 4.8 | |
Age | 68 | 73 | 65 | 70 | <0.001 |
median (min–max) | (19–85) | (50–92) | (29–85) | (19–92) | |
IQR | 11 | 10 | 19.5 | 13 | |
Age over 65 (%) | 28 | 44 | 6 | 78 | 0.013 |
(47.46%) | (62.86%) | (30%) | (52.35%) | ||
Age over 80 (%) | 4 | 16 | 3 | 23 | 0.001 |
(6.78%) | (22.86%) | (15%) | (15.44%) | ||
Charlson | 8 | 9 | 8.5 | 8 | 0.022 |
median (min–max) | (2–11) | (5–13) | (2–12) | (2–13) | |
IQR | 2 | 2 | 5.5 | 3 | |
Charlson ≥ 7 (%) | 45 | 63 | 14 | 122 | 0.043 |
(76.27%) | (90%) | (70%) | (81.88%) | ||
Charlson ≥ 10 (%) | 10 | 27 | 7 | 44 | 0.023 |
(16.95%) | (38.57%) | (35%) | (29.53%) | ||
Cardiopathy (%) | 28 | 28 | 7 | 63 | 0.54 |
(47.46%) | (40%) | (35%) | (42.28%) | ||
SCreatinine (mg/dL) | 2.9 | 2.7 | 2.5 | 2.78 | 0.761 |
median (min–max) | (0.90–6.80) | (1–6.40) | (1.15–4.90) | (0.90–6.80) | |
IQR | 1.7 | 1.3 | 1.75 | 1.47 | |
eGFR-EPI (mL/min) | 20.4 | 19.85 | 18.9 | 20 | 0.214 |
median (min–max) | (6.30–79.70) | (7.70–61) | (8.80–67.80) | (6.3–79.7) | |
IQR | 19.3 | 9.1 | 10.8 | 11.2 | |
GFR < 15 mL/min at enrolment n (%) | 16 | 15 | 4 | 35 | 0.693 |
(27.12%) | (21.43%) | (20%) | (23.49%) | ||
GFR < 10 mL/min at enrollment n (%) | 7 | 5 | 1 | 13 | 0.522 |
(11.86%) | (7.14%) | (5%) | (8.72%) | ||
Proteinuria (g/day) | 1.6 | 0.5 | 1.4 | 0.8 | 0.017 |
Median (min–max) | (0.10–10) | (0.08–15.80) | (0.20–10.40) | (0.04–15.80) | |
IQR | 4.1 | 1.8 | 2.8 | 2.95 | |
Proteinuria ≥ 1 g/day (%) | 40 | 27 | 11 | 78 | 0.004 |
(67.80%) | (38.57%) | (55%) | (52.35%) | ||
Proteinuria ≥ 3 g/day (%) | 23 | 13 | 5 | 41 | 0.001 |
(38.98%) | (18.57%) | (25%) | (27.52%) |
Non Diabetics | Vegan Suppl. | With Protein-Free Food | Other | All Cases | p among Groups |
---|---|---|---|---|---|
N (%) | 156 (52%) | 89 (29.67%) | 55 (18.33%) | 300 (100%) | - |
Males (%) | 104 (66.67%) | 59 (66.29%) | 27 (49.09%) | 190 (63.33%) | 0.053 |
BMI | 25.72 | 26.3 | 24.87 | 25.71 | 0.08 |
median (min–max) | (13.32–41.03) | (17.96–42.52) | (17.81–46.67) | (13.32–46.67) | |
IQR | 4.74 | 5.24 | 5.5 | 4.79 | |
Age | 63 | 78 | 72 | 70 | <0.001 |
median (min–max) | (23−86) | (26–97) | (23−88) | (23–97) | |
IQR | 25 | 12 | 22 | 22.5 | |
Age over 65 (%) | 58 | 38 | 22 | 118 | 0.692 |
(37.18%) | (42.70%) | (40%) | (39.33%) | ||
Age over 80 (%) | 16 | 27 | 13 | 66 | 0.001 |
(10.26%) | (30.13%) | (23.64%) | (22%) | ||
Charlson | 5 | 7 | 6 | 6 | <0.001 |
median (min–max) | (2–12) | (2–13) | (2–11) | (2–13) | |
IQR | 4 | 2 | 4 | 4 | |
Charlson ≥ 7 (%) | 46 | 55 | 23 | 124 | <0.001 |
(29.48%) | (61.80%) | (41.81%) | (41.33%) | ||
Charlson ≥ 10 (%) | 7 | 15 | 5 | 27 | 0.005 |
(4.49%) | (16.85%) | (9.09%) | (9%) | ||
Cardiopathy (%) | 73 | 39 | 33 | 145 | 0.144 |
(46.80%) | (43.82%) | (60%) | (48.33%) | ||
SCreatinine (mg/dL) | 3.2 | 2.4 | 2.49 | 2.8 | <0.001 |
median (min–max) | (0.55–16) | (1.05–7) | (0.60–6.70) | (0.55–16) | |
IQR | 2.5 | 1.3 | 1.38 | 1.88 | |
eGFR-EPI (mL/min) | 17.15 | 21.4 | 24.3 | 20 | 0.367 |
median (min–max) | (3–125.70) | (6.60–73.10) | (5.70–127.1) | (3–127.10) | |
IQR | 14.2 | 13.8 | 17.8 | 15.9 | |
GFR < 15 mL/min at enrolment n (%) | 64 | 17 | 9 | 90 | 0.001 |
(41.02%) | (19.10%) | (16.36%) | (30%) | ||
GFR < 10 mL/min at enrolment n (%) | 22 | 5 | 4 | 31 | 0.107 |
(14.10%) | (5.62%) | (7.28%) | (10.33%) | ||
Proteinuria (g/day) | 1 | 0.2 | 0.8 | 0.7 | <0.001 |
Median (min–max) | (0.10–8.20) | (0.04–6.10) | (0.10–11) | (0.04–11) | |
IQR | 2.1 | 0.45 | 1.8 | 1.7 | |
Proteinuria ≥ 1 g/day (%) | 85 (54.49%) | 15 (16.85%) | 24 (43.64%) | 124 (41.33%) | 0.001 |
Proteinuria ≥ 3 g/day (%) | 27 (7.31%) | 6 (6.74%) | 8 (14.55%) | 41 (13.67%) | 0.096 |
Diabetic Patients | Type 1 | Type 2 | p | Type 2 CKD | Type 2 Comorb | p | Type 2 PtU ≥ 1 g | Type 2 PtU < 1 g | p |
---|---|---|---|---|---|---|---|---|---|
149 | 12 | 137 | 42 | 95 | - | 70 | 67 | - | |
Males (%) | 4 | 83 | 0.076 | 26 | 57 | 0.833 | 47 | 36 | 0.109 |
(33.33%) | (60.58%) | (61.90%) | (60%) | (67.10%) | (53.70%) | ||||
BMI | 23.24 | 27.39 | 0.014 | 27.97 | 27.18 | 0.17 | 27.55 | 26.99 | 0.84 |
median (min–max) | (18.49–29.32) | (18.33–44.92) | (18.77–41.03) | (20.37–44.92) | (19.15–41.03) | (20.37–44.92) | |||
IQR | 4.98 | 4.61 | 6.28 | 3.99 | 4.57 | 4.37 | |||
Age | 43.5 | 71 | 0.031 | 66.5 | 72 | 0.181 | 68 | 73 | 0 |
median (min–max) | (29–62) | (19–92) | (46–85) | (19–92) | (47–86) | (19–92) | |||
IQR | 15.5 | 12 | 10 | 11 | 11 | 13 | |||
Age over 65 (%) | 0 | 119 (86.86%) | - | 31 (73.81%) | 88 (92.63%) | 0.001 | 46 (65.70%) | 61 (91%) | 0 |
Age over 80 (%) | 0 | 40 (29.20%) | - | 6 (14.28%) | 34 (35.79%) | 0.011 | 5 (7.1%) | 18 (26.90%) | 0.002 |
Charlson | 4 | 9 | 0.06 | 8 | 9 | 0.032 | 8 | 9 | 0.035 |
median (min–max) | (2–8) | (2–13) | (5–11) | (2–13) | (5–11) | (2–13) | |||
IQR | 1.5 | 3 | 2 | 2 | 2 | 2 | |||
Charlson ≥ 7 (%) | 2 (16.17%) | 120 (87.59%) | 0 | 33 (78.57%) | 87 (91.58%) | 0.033 | 58 (82.90%) | 62 (92.50%) | 0.071 |
Charlson ≥ 10 (%) | 0 (0%) | 44 (32.12%) | 0.019 | 6 (14.29%) | 38 (40%) | 0.0002 | 14 (20.29%) | 30 (44.12%) | 0.003 |
Cardiopathy (%) | 3 (25%) | 93 (67.88%) | 0.009 | 25 (59.52%) | 68 (71.58%) | 0.163 | 41 (58.60%) | 52 (77.60%) | 0.013 |
SCreatinine | 2.45 | 2.8 | 0.393 | 2.6 | 2.9 | 0.858 | 2.89 | 2.7 | 0.695 |
median (min–max) | (0.9–4.7) | (1–6.8) | (1–6.4) | (1.1–6.8) | (1–6.8) | (1.4–5) | |||
mg/dL IQR | 1.95 | 1.4 | 1.5 | 1.4 | 1.6 | 2.4 | |||
eGFR-EPI (mL/min) | 24.95 | 19.8 | 0.026 | 20.85 | 19.5 | 0.993 | 19.3 | 19.9 | 0.875 |
median (min–max) | (12.10–79.70) | (6.3–75.5) | (6.3071.60) | (7.4–77.7) | (6.3–75.5) | (7.7–54.5) | |||
IQR | 21.3 | 10.7 | 14.1 | 11.2 | 11.5 | 10.1 | |||
GFR < 15 at start n (%) | 3 (25%) | 32 (23.36%) | 0.897 | 8 (19.05%) | 24 (25.26%) | 0.428 | 16 (22.90%) | 16 (23.90%) | 0.524 |
GFR < 10 at start n (%) | 0 | 13 (9.49%) | 0.264 | 5 (11.90%) | 8 (8.42%) | 0.472 | 10 (14.30%) | 3 (4.5%) | 0.05 |
PtU (g/day) | 3.05 | 1 | 0.041 | 3.25 | 0.5 | 0 | 3 | 0.25 | 0 |
median (min–max) | (0.2–10.4) | (0.1–15.8) | (0.2–15.8) | (0.08–7) | (1–15.8) | (0.1–0.9) | |||
IQR | 4.1 | 2.67 | 3.5 | 1.3 | 3.2 | 0.3 |
MORTALITY | |||||
---|---|---|---|---|---|
n/N | Crude RR (95% CIs) | p Value | Adjusted HR (95% CIs) | p Value | |
Diabetes | 52/149 | 1.4534 | <0.0001 | 1.146 | 0.5173 |
No-Diabetes | 51/300 | (1.1831–1.7855) | (0.758–1.733) | ||
Charlson index | <0.0001 | <0.0001 | |||
<7 | 14/203 | 4.0188 | 5.155 | ||
≥7 | 89/246 | (2.4465–6.6014) | (2.851–9.320) | ||
Proteinuria (g/day) | <0.0001 | 0.0615 | |||
<1 | 74/247 | 0.6959 | 0.654 | ||
≥1 | 29/202 | (0.5928–0.8170) | (0.419–1.021) | ||
GFR (mL/m) | 0.1065 | 0.0928 | |||
<30 | 85/344 | 0.9071 | 0.644 | ||
≥30 | 18/105 | (0.8144–1.0104) | (0.385–1.076) | ||
RRT START | |||||
n/N | Crude RR (95% CIs) | p Value | Adjusted HR (95% CIs) | p Value | |
Diabetes | 32/149 | 0.9658 | 0.6584 | 0.781 | 0.3175 |
No-diabetes | 70/300 | (0.8303–1.1234) | (0.481–1.268) | ||
Charlson index | 0.0138 | 0.1098 | |||
<7 | 57/246 | 0.7529 | 0.692 | ||
≥7 | 45/203 | (0.6090–0.9308) | (0.441–1.087) | ||
Proteinuria (g/day) | <0.0001 | <0.0001 | |||
<1 | 34/247 | 1.8415 | 3.703 | ||
≥1 | 68/202 | (1.3823–2.4533) | (2.409–5.691) | ||
GFR (mL/m) | <0.0001 | <0.0001 | |||
<30 | 96/344 | 0.7594 | 0.115 | ||
≥30 | 6/105 | (0.6994–0.8245) | (0.005–0.267) |
Patients | Diabetes | No Diabetes | p Diab Non-Diab |
---|---|---|---|
N 168 | 41 | 127 | - |
sCreatinine mg/dL | 2.89 | 2.67 | 0.587 |
median (min–max) | (1.27–4.93) | (1.20–9) | |
IQR | 3.33 | 1.7 | |
Proteinuria g/day | 0.73 | 0.8 | 0.924 |
median (min–max) | (0.02–11) | (0–7.9) | |
IQR | 1.94 | 1.79 | |
s-albumin g/dL | 3.72 | 3.8 | 0.627 |
median (min–max) | (1.8–4.7) | (2.39–5.7) | |
IQR | 0.7 | 0.6 | |
Albumin < 3 g/dL n (%) | 9 (21.95%) | 12 (9.45%) | 0.021 |
PTH pg/mL | 114 | 94.9 | 0.014 |
Median (min–max) | (41–734) | (8–848) | |
IQR | 88.95 | 94.4 | |
Urea mg/dL | 96 | 90 | 0.335 |
median (min–max) | (37–232) | (19–280) | |
IQR | 63 | 61 | |
HCO3 mEq/dL | 26.1 | 25.1 | 0.891 |
median (min–max) | (17.7–39) | (14.3–34) | |
IQR | 5.35 | 4.4 | |
Protein intake (Mitch formula) g/kg/day | 0.47 | 0.47 | 0.894 |
median (min–max) | (0.27–0.76) | (0.21–0.86) | |
IQR | 0.21 | 0.17 | |
Hb1ac (%) | 7.2 | ||
Median (min–max) | (4.5–9.8) | ||
IQR | 11.5 |
© 2016 by the authors; licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC-BY) license (http://creativecommons.org/licenses/by/4.0/).
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Piccoli, G.B.; Ventrella, F.; Capizzi, I.; Vigotti, F.N.; Mongilardi, E.; Grassi, G.; Loi, V.; Cabiddu, G.; Avagnina, P.; Versino, E. Low-Protein Diets in Diabetic Chronic Kidney Disease (CKD) Patients: Are They Feasible and Worth the Effort? Nutrients 2016, 8, 649. https://doi.org/10.3390/nu8100649
Piccoli GB, Ventrella F, Capizzi I, Vigotti FN, Mongilardi E, Grassi G, Loi V, Cabiddu G, Avagnina P, Versino E. Low-Protein Diets in Diabetic Chronic Kidney Disease (CKD) Patients: Are They Feasible and Worth the Effort? Nutrients. 2016; 8(10):649. https://doi.org/10.3390/nu8100649
Chicago/Turabian StylePiccoli, Giorgina B., Federica Ventrella, Irene Capizzi, Federica N. Vigotti, Elena Mongilardi, Giorgio Grassi, Valentina Loi, Gianfranca Cabiddu, Paolo Avagnina, and Elisabetta Versino. 2016. "Low-Protein Diets in Diabetic Chronic Kidney Disease (CKD) Patients: Are They Feasible and Worth the Effort?" Nutrients 8, no. 10: 649. https://doi.org/10.3390/nu8100649