Andreea Mihalache1, Liliana Garneata2, Carmen Antonia Mocanu3, Tudor-Petrisor Simionescu3, Gabriel Mircescu4. 1. "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania. 2. Department of Nephrology, "Carol Davila" University of Medicine and Pharmacy, "Dr Carol Davila" Teaching Hospital of Nephrology, 4 Calea Grivitei, Sector 1, 010731, Bucharest, Romania. lilianagarna@yahoo.com. 3. Department of Nephrology, Carol Davila" University of Medicine and Pharmacy, "Dr Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania. 4. Department of Nephrology, "Carol Davila" University of Medicine and Pharmacy, "Dr Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania.
Abstract
PURPOSE: To assess the associations between effects of low salt, low protein diet supplemented with keto-analogues (sLPD)-on salt intake, blood pressure (BP) and cardiovascular events (CVEs) in patients with advanced diabetic kidney disease (DKD) and heavy proteinuria. METHODS: Prospective, single-center study (total duration of 15 months), enrolling 92 patients with advanced DKD (median eGFR 11.7 ml/min) and heavy proteinuria (median 4.8 g/g creatininuria). The intervention consisted in a low salt-low protein (0.6 g/kg-day) diet (sLPD) under intensive nutritional counselling, and adjustment of antihypertensive therapy. The endpoints of this sub-analysis were a salt intake ≤ 5 g/day, a mean blood pressure (MAP) ≤ 97 mmHg, corresponding to KDIGO target of 130/80 mmHg, and the rate of CVEs. RESULTS: Salt intake decreased with 2.5 g/day and the proportion of patients reaching the salt intake endpoint increased with 58%. A salt intake ≤ 5 g/day was associated with a reduced MAP, BMI, proteinuria, fractional excretion of sodium, and eGFR, suggesting a salt-related volume contraction but was not related to protein intake. Mean arterial pressure decreased with 13 mmHg. MAP ≤ 97 mmHg was associated with lower proteinuria, salt, and protein intake, but the contribution of salt intake cannot be differentiated from that of protein intake. CVEs occurred in 20% of patients and were independently related to a lower age and MAP, and increased comorbidities. eGFR only minimally declined and no renal adverse events were noted. sLPD was nutritionally safe. CONCLUSIONS: The multifactorial personalized intervention allowed a stable MAP reduction to KDIGO recommended levels (≤ 97 mmHg), related to the decrease in salt and protein intake. However, BP lower than 130/80 mmHg increased the cardiovascular but not the renal risk in heavy proteinuric patients with advanced DKD. TRIAL REGISTRATION NUMBER: 0341507433: NCT03415074. Registered 02/02/2015 in US National Library of Medicine, ClinicalTrials.gov (NCT).
PURPOSE: To assess the associations between effects of low salt, low protein diet supplemented with keto-analogues (sLPD)-on salt intake, blood pressure (BP) and cardiovascular events (CVEs) in patients with advanced diabetic kidney disease (DKD) and heavy proteinuria. METHODS: Prospective, single-center study (total duration of 15 months), enrolling 92 patients with advanced DKD (median eGFR 11.7 ml/min) and heavy proteinuria (median 4.8 g/g creatininuria). The intervention consisted in a low salt-low protein (0.6 g/kg-day) diet (sLPD) under intensive nutritional counselling, and adjustment of antihypertensive therapy. The endpoints of this sub-analysis were a salt intake ≤ 5 g/day, a mean blood pressure (MAP) ≤ 97 mmHg, corresponding to KDIGO target of 130/80 mmHg, and the rate of CVEs. RESULTS:Salt intake decreased with 2.5 g/day and the proportion of patients reaching the salt intake endpoint increased with 58%. A salt intake ≤ 5 g/day was associated with a reduced MAP, BMI, proteinuria, fractional excretion of sodium, and eGFR, suggesting a salt-related volume contraction but was not related to protein intake. Mean arterial pressure decreased with 13 mmHg. MAP ≤ 97 mmHg was associated with lower proteinuria, salt, and protein intake, but the contribution of salt intake cannot be differentiated from that of protein intake. CVEs occurred in 20% of patients and were independently related to a lower age and MAP, and increased comorbidities. eGFR only minimally declined and no renal adverse events were noted. sLPD was nutritionally safe. CONCLUSIONS: The multifactorial personalized intervention allowed a stable MAP reduction to KDIGO recommended levels (≤ 97 mmHg), related to the decrease in salt and protein intake. However, BP lower than 130/80 mmHg increased the cardiovascular but not the renal risk in heavy proteinuric patients with advanced DKD. TRIAL REGISTRATION NUMBER: 0341507433: NCT03415074. Registered 02/02/2015 in US National Library of Medicine, ClinicalTrials.gov (NCT).
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