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Effect of methyl-donor nutrient supplementation on methylation profile of inflammatory-related genes in lupus patients with obesity: a clinical trial

Grant number: 21/09745-5
Support Opportunities:Scholarships in Brazil - Master
Effective date (Start): February 01, 2022
Effective date (End): March 31, 2024
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Carolina Nicoletti Ferreira Fino
Grantee:Jhulia Caroline Nunes Leal da Mota
Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
Associated research grant:20/01893-2 - Progress in epigenetics on autoimmune rheumatic diseases: from basic studies to bedside in Lupus Erythematosus, Systemic, AP.JP
Associated scholarship(s):23/02401-4 - Evaluation of cardiometabolic risk in patients with systemic lupus erythematosus and obesity: Project metainflammation, BE.EP.MS

Abstract

To achieve the proposed objectives, we will conduce a controlled clinical study of parallel groups. For this study, we will recruit pre-menopausal SLE female patients, between 18 to 40 years old, with normal weight (BMI between 18.5 and 24.9 kg/m2)or obesity (BMI between 30 to 45 kg/m2), attending a tertiary Rheumatology Outpatient Clinic that meet the classification criteria according to SLICC criteria [126]. More information about inclusion and exclusion criteria has been described in the general methods and materials section. Inactive lupus patients (SLEDAI <4) under prednisone <10mg/day, with stable immunosuppressive drugs for 4 months and hydroxicloroquine will be randomized into four groups: 1. Obese Supplementation group, which SLE + obesity will receive vitamin B12 and folic acid supplementation, in addition to the usual therapy; 2. Obese Control group, which SLE + obesity patient will receive placebo administration in addition to usual medical treatment; 3. Normal-weight Supplementation group, which SLE + normal weight patients will receive vitamin B12 and folic acid supplementation, in addition to the usual therapy and 4. Normal-weight Control group, which SLE + normal weight patient will receive placebo administration in addition to usual medical treatment. The intervention period will be 3 months. The supplementation has been described in the general methods and materials section. Participants will be assessed before (PRE) and after (POST) the supplementation, using an extensive battery of outcomes related to objectives proposed. These will include blood samples and subcutaneous adipose tissue collection. Both samples will be used to epigenetic and gene expression analysis. Blood samples will also be used for inflammatory and biochemical analysis (lipid profile, glucose, adipokines, vitamin B12 and folic acid concentrations). Anthropometric parameters and dietary intake will be also assesse. Clinical disease parameters (e.g., age of onset, duration of disease since diagnosis, current and cumulative dose of medications) will be obtained through medical record review and personal interview (Figure 10). In both periods (PRE and POST), patients will report to the laboratory at 08:00 hour, following a 12-hour overnight fast. Ethical considerations have been described in the general methods and materials section. This study has been designed in accordance with the recommendations of the consolidated standards of reporting trials (CONSORT) group, and will be registered at clinicaltrials.gov prior to initiation. For epigenetic analysis, the bisulfite-treated genomic DNA will be amplified, hybridized with Human Methylation EPIC beadchip (Illumina) and digitized using the Illuminai Scan SQ platform. The intensity of the images will be extracted with Genome Studio Methylation software (1.9.0, Illumina). The obtained data will be analyzed by bioinformatics analysis to verify which inflammatory pathway genes were differently methylated between groups. The bioinformatics analysis will be performed in partnership with the team of Prof Ana Belén Crujeiras and Prof Amalia, Spain.

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