Effect of an Intensive Weight-Loss Lifestyle Intervention on Kidney Function: A Randomized Controlled Trial
Authors: Díaz-López Andrés , Becerra-Tomás Nerea , Ruiz Verónica , Toledo Estefanía , Babio Nancy , Corella Dolores , Fíto Montse , Romaguera Dora , Vioque Jesús , Alonso-Gómez Ángel M , Wärnberg Julia , Martínez J.Alfredo , Serra-Majem Luís , Estruch Ramon , Tinahones Francisco J , Lapetra José , Pintó Xavier , Tur Josep , López-Miranda José , Ibañez Naomi Cano , Delgado-Rodríguez Miguel , Matía-Martín Pilar , Daimiel Lidia , Paz Jose Antonio de la , Vidal Josep , Vázquez Clotilde , Ruiz-Canela Miguel , Bulló Mònica , Sorlí José V , Goday Albert , Fiol Miquel , García-de-la-Hera Manoli , Sierra Lucas Tojal , Pérez-Farinós Napoleón , Zulet Maria Angeles , Sánchez-Villegas Almudena , Sacanella Emilio , Fernández-García José Carlos , Santos-Lozano José Manuel , Gimenez-Gracia Miquel , Bibiloni Maria del Mar , Diez-Espino Javier , Ortega-Azorin Carolina , Castañer Olga , Morey Marga , Torres-Collado Laura , Sanchez Carolina Sorto , Muñoz Miguel Ángel , Ros Emilio , Martínez-González Miguel A , Salas-Salvadó Jordi 
Published: November 2020

BackgroundLarge randomized trials testing the effect of a multifactorial weight-loss lifestyle intervention including Mediterranean diet (MedDiet) on renal function are lacking. Here, we evaluated the 1-year efficacy of an intensive weight-loss intervention with an energy-reduced MedDiet (erMedDiet) plus increased physical activity (PA) on renal function.MethodsRandomized controlled “PREvención con DIeta MEDiterránea-Plus” (PREDIMED-Plus) trial conducted in 23 Spanish centers comprising 208 primary care clinics. Overweight/obese (n=6719) adults aged 55-75 years with metabolic syndrome were randomly assigned (1:1) to an intensive weight-loss lifestyle intervention with an erMedDiet, PA promotion and behavioral support (intervention) or usual-care advice to adhere to an energy-unrestricted MedDiet (control) between Sept-2013 and Dec-2016. The primary outcome was 1-year change in estimated glomerular filtration rate (eGFR). Secondary outcomes were changes in urine albumin-to-creatinine ratio (UACR), incidence of chronic kidney disease (CKD, eGFR<60 ml/min/1.73m2 or stage 3 CKD) and micro-macroalbuminuria (UACR≥30 mg/g), and reversion of stage 3 to 2 CKD (eGFR between 60-<90 ml/min/1.73m2) or micro-macroalbuminuria.ResultsAfter 1-year eGFR declined by 0.66 and 1.25 ml/min/1.73m2 in the intervention and control groups, respectively (mean difference, 0.58 ml/min/1.73m2; 95%CI, 0.15 to 1.02). There were no between-group differences in mean UACR or micro-macroalbuminuria changes. CKD incidence and reversion of stage 3 to 2 CKD were 40% lower (HR 0.60; 0.44 to 0.82) and 92% higher (HR 1.92; 1.35 to 2.73), respectively, in the intervention group.ConclusionsThe PREDIMED-Plus lifestyle intervention is an effective approach for preserving renal function and preventing/delaying CKD progression in overweight/obese adults.Trial RegistrationThis study was registered at the International Standard Randomized Controlled Trial. isrctn.com Identifier: ISRCTN89898870. Registration date: 24 July 2014-Retrospectively registered.