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Effect of an Intensive Weight-Loss Lifestyle Intervention on Kidney Function: A Randomized Controlled Trial.

Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Universitat Rovira i Virgili, Reus, Spain. Institut d'Investigació Sanitària Pere Virgili (IISPV), Reus, Spain. Nutrition Unit, University Hospital of Sant Joan de Reus, Reus, Spain. Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain. Department of Preventive Medicine and Public Health, IdiSNA, University of Navarra, Pamplona, Spain. Department of Preventive Medicine, University of Valencia, Valencia, Spain. Cardiovascular Risk and Nutrition research group (CARIN), Hospital del Mar Research Institute (IMIM), Barcelona, Spain. Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain. ISABIAL-FISABIO, Miguel Hernandez University, Alicante, Spain. CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain. Department of Cardiology, Organización Sanitaria Integrada (OSI) ARABA, University Hospital Araba, Vitoria-Gasteiz, Spain. Department of Nursing, Institute of Biomedical Research in Malaga (IBIMA), University of Málaga, Málaga, Spain. Department of Nutrition, Food Science and Physiology, IdiSNA, University of Navarra, Pamplona, Spain. Nutritional Genomics and Epigenomics Group, IMDEA Food, CEI UAM + CSIC, Madrid, Spain. Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Preventive Medicine Service, Centro Hospitalario Universitario Insular Materno Infantil (CHUIMI), Canarian Health Service, Las Palmas, Spain. Department of Internal Medicine, Institutd'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain. Department of Endocrinology, Instituto de Investigación Biomédica de Málaga (IBIMA), Virgen de la Victoria Hospital, University of Málaga, Málaga, Spain. Department of Family Medicine, Research Unit, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain. Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain. Research Group on Community Nutrition & Oxidative Stress, University of Balearic Islands, Palma de Mallorca, Spain. Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain. Department of Preventive Medicine, University of Granada, Granada, Spain. Division of Preventive Medicine, Faculty of Medicine, University of Jaén, Jaén, Spain. Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Madrid, Spain. Institute of Biomedicine (IBIOMED), University of León, León, Spain. Departament of Endocrinology, IDIBAPS, Hospital Clínic, University of Barcelona, Barcelona, Spain. CIBER Diabetes y Enfermedades Metabólicas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain. Department of Endocrinology and Nutrition, Hospital Fundación Jimenez Díaz, Instituto de Investigaciones Biomédicas IISFJD, University Autonoma, Madrid, Spain. Department of Public Health, University of Málaga, Institute of Biomedical Research in Malaga (IBIMA), Málaga, Spain. Lipid Clinic, Department of Endocrinology and Nutrition, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, Barcelona, Spain. Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Universitat Rovira i Virgili, Reus, Spain, jordi.salas@urv.cat. Institut d'Investigació Sanitària Pere Virgili (IISPV), Reus, Spain, jordi.salas@urv.cat. Nutrition Unit, University Hospital of Sant Joan de Reus, Reus, Spain, jordi.salas@urv.cat. Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain, jordi.salas@urv.cat.

American journal of nephrology. 2021;(1):45-58
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Abstract

INTRODUCTION Large 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. METHODS Randomized controlled "PREvención con DIeta MEDiterránea-Plus" (PREDIMED-Plus) trial is conducted in 23 Spanish centers comprising 208 primary care clinics. Overweight/obese (n = 6,719) 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 September 2013 and December 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 moderately/severely impaired eGFR (<60 mL/min/1.73 m2) and micro- to macroalbuminuria (UACR ≥30 mg/g), and reversion of moderately (45 to <60 mL/min/1.73 m2) to mildly impaired GFR (60 to <90 mL/min/1.73 m2) or micro- to macroalbuminuria. RESULTS After 1 year, eGFR declined by 0.66 and 1.25 mL/min/1.73 m2 in the intervention and control groups, respectively (mean difference, 0.58 mL/min/1.73 m2; 95% CI: 0.15-1.02). There were no between-group differences in mean UACR or micro- to macroalbuminuria changes. Moderately/severely impaired eGFR incidence and reversion of moderately to mildly impaired GFR were 40% lower (HR 0.60; 0.44-0.82) and 92% higher (HR 1.92; 1.35-2.73), respectively, in the intervention group. CONCLUSIONS The PREDIMED-Plus lifestyle intervention approach may preserve renal function and delay CKD progression in overweight/obese adults.

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MeSH terms : Kidney