Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED): a randomised, double-blind, placebo-controlled, crossover trial

The Lancet. Diabetes & Endocrinology
Aneliya ParvanovaPROCEED Study Organization and the Scientific Writing Academy (SWA) 2016

Abstract

Macroalbuminuria predicts renal and cardiovascular events in patients with type 2 diabetes. We aimed to assess the albuminuria-lowering effects of salt restriction, paricalcitol therapy, or both, in this population. In this randomised, double-blind, placebo-controlled, crossover trial, we recruited adult patients with type 2 diabetes from six diabetology outpatient clinics in northern Italy, with 24 h albuminuria of more than 300 mg despite 100 mg per day losartan therapy, blood pressure of less than 140/90 mm Hg, serum creatinine concentration of less than 2 mg/dL, stable renal function on stable renin-angiotensin system inhibitor therapy with a fixed dose of losartan, parathyroid hormone concentration of 20 pg/mL to <110 pg/mL, serum calcium concentration of less than 9·5 mg/dL, and serum phosphate concentration of less than 5 mg/dL, who had been more than 80% compliant with placebo treatment during a 1 month placebo run-in. We allocated patients 1:1 with computer-generated randomisation to an open-label 3 month high-sodium (>200 mEq [4·8 g] per day) or low-sodium (<100 mEq [2·4 g] per day) diet and, within each diet group, to a 1 month double-blind treatment period of oral paricalcitol (2 μg per day) or placebo, followed by ...Continue Reading

Citations

Apr 9, 2020·Diabetes, Obesity & Metabolism·Jonatan Barrera-Chimal, Frédéric Jaisser
May 30, 2020·Journal of Clinical Medicine·Beatriz Fernandez-FernandezAlberto Ortiz
Sep 27, 2018·Frontiers in Medicine·Samuel Mon-Wei YuBelinda Jim
Jul 25, 2019·Nutrients·Sol CarriazoMaria Dolores Sanchez-Niño
Jul 8, 2020·Journal of the American Society of Nephrology : JASN·Sandra Rayego-MateosMarta Ruiz-Ortega
Dec 15, 2020·Journal of Renal Nutrition : the Official Journal of the Council on Renal Nutrition of the National Kidney Foundation·Huamin ZhouXianhui Qin

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