Introduction and Aims: Concerns on a possible negative impact of low-protein diets (LPD) on nutrition in CKD, mainly in frail patients, have been raised. We evaluated the short- and long-term effects of a LPD supplemented with ketoacids on nutritional status and body composition in diabetic CKD patients.

Methods: In this case-controlled study were enrolled 197 consecutive patients with advanced CKD (stages 3/5) on a LPD (0.5-0.6 g proteins/kg iBW/day; 30-35 kcal/kg iBW/day; 100 mmol salt/day) supplemented with ketoacids (Ketosteril®, 1 tab/ 5-7 kg BW/day). Diabetics patients (DM, n=81; DM1, 6%; DM2, 94%) and non-diabetes controls (CON, n=116) were compared along either a short (6-months) or long (at least 24 months) period-time. Primary outcome was nutritional status.

Results: DM and CON groups were comparable for gender (Male, 58 vs. 55%), age (66±9 vs. 63±18 yrs), renal function (eGFR, 22.7±13.0 vs. 24.0±13.0 mL/min/1.73 m2) and lab profile; body weight (BW) was slightly higher in DM (68.9±14.3 vs. 66.6±15.1, NS). In the 6-mo follow-up, in both groups it reduced urea (DM: 131±58 to 105±49 mg/dl, p<0.05; CON: 115±52 to 88±36, p<0.05) and cholesterol (p<0.05); fasting glucose dropped in DM (122±54 to 103±29 mg/dl, p<0.05) without changes in insulin dose; albumin and triglycerides did not vary. BW lowered (DM: to 65.1±12.1 kg, p<0.05; CON: to 64.1±15.1, p<0.05); such BW decline entirely occurred in the first two months and thereafter remained stable; as attain body composition, it reduced total body water (TBW; -1 Lt, p<0.05) (no diuretic changes), fat mass (FM; -1 kg, p<0.05) and fat free mass (FFM; -1 kg, NS); fractional TBW, FM and FFM were unchanged; waist/hip (W/H) ratio was unchanged too. In the subjects (DM=29; CON=35) studied in the long-term (38±13 months), albumin was stable; BW reduced by similar extent of the short-term study (DM and CON, p<0.05) during the first months and remained stable in the long-term; absolute FM reduced (p<0.05), and absolute FFM and fractional FM and FFM were unchanged. Muscle strength measured by dynamometry was near lower normal levels at baseline (DM, 20.8±7.9 kg; CON, 25.0±7.8) and did not changed at 6-mo and 38-mo observations.

Conclusions: In diabetic patients with advanced CKD, compared with non-diabetic controls, a low-protein ketodiet while improving the metabolic status does not worsen nutritional status, body composition and muscle fitness in the short- and long-term follow-up.

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