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Promotion of healthy lifestyle in patients with Systemic Erythematosus Lupus: effects on cardiometabolic risks factors the randomized and controlled clinical trial living well with Lupus

Grant number: 19/15231-4
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): October 01, 2019
Effective date (End): September 30, 2023
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Bruno Gualano
Grantee:Sofia Mendes Sieczkowska
Home Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Systemic Lupus Erythematosus is a multisystemic autoimmune rheumatic disease characterized by associated symptoms, such as skin lesions, Arthritis, renal disorders, neurological disorders and hematological changes. Patients with Lupus present a high prevalence of cardiovascular diseases, being these the main causes of morbidity and mortality. The healthy lifestyle such as elevated physical activity levels and reduced ultraprocessed food uptake is crucial for general status healthy. Thus, interventions combining instructions to healthy lifestyle (e.g., physical activity and changes in dietary intake) may be potential non-pharmacological strategies to improve cardiovascular health. Therefore, the objective of the present study is to investigate the effects of a healthy lifestyle intervention in cardiometabolic risk factors (visceral fat, aerobic capacity, arterial hypertension, dyslipidemia, insulin resistance, and endothelial dysfunction) in patients with Lupus. The patients will be randomly allocated into two groups: intervention or control group. The intervention group will undergo to 6-month intervention, focused on a lifestyle change, through a personalized recommendation of physical activity (structured and unstructured) and changes in dietary intake. Before and at the end of the intervention, the following evaluations will be carried out: (1) physical activity level and food consumption; (2) cardiovascular risk score (primary outcome); (3) anthropometry and visceral fat; (4) aerobic capacity; (5) blood pressure; (6) blood collection and OGTT; (7) endothelial microparticles, endothelial progenitor cells, blood flow, and endothelial function; (8) clinical parameters. Our hypothesis is that intervention for lifestyle modification results in a reduction in cardiometabolic risk factors in patients with Lupus. The findings of this study could inform new clinical and population guidelines for the multidisciplinary treatment in Systemic Lupus Erythematosus, with a view to the prevention of cardiovascular events. (AU)