Obesity, Abdominal
Conditions
Interventions
This is a randomized, double-blind, placebo-controlled crossover clinical trial evaluating dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, compared with placebo in 50 adults with ob
Sponsors
Universidade Federal de São Paulo - UNIFESP
Universidade Federal de São Paulo - UNIFESP
Eligibility
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: Adults of either sex; age between 30 and 80 years; body mass index equal to or greater than 30 kg/m²; glycated hemoglobin lower than 6.5%; insulin resistance defined as a Homeostatic Model Assessment for Insulin Resistance index equal to or greater than 2.19 for men or equal to or greater than 2.18 for women; estimated glomerular filtration rate equal to or greater than 60 mL/min/1.73 m²; ability to understand and sign the Informed Consent FormAbility and willingness to provide written informed consent prior to participation in the study.
Exclusion criteria
Exclusion criteria: Diabetes mellitus; endocrinopathies that may interfere with glucose or lipid metabolism; familial dyslipidemias; use of anticoagulant medications; acute inflammatory diseases; active rheumatologic diseases; malignant neoplasm diagnosed within the previous five years; alcohol or illicit drug abuse; pregnancy or breastfeeding; estimated glomerular filtration rate lower than 60 mL/min/1.73 m²; known hypersensitivity to dapagliflozin or any component of the formulation; concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in innate immune profile, assessed by the proportion and functional activity of Th17 lymphocytes and regulatory T cells (CD4+CD25+FOXP3+), from baseline to 3 months and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in endothelial injury markers, assessed by circulating endothelial microparticles, from baseline to 3 and 6 months ;Change in epigenetic markers, assessed by the expression levels of microRNAs (miR-21 and miR-126), from baseline to 3 and 6 months;Change in inflammatory biomarkers, including C-reactive protein (CRP), TNF-a, IL-6, and IL-10;Change in metabolic parameters, including fasting glucose and lipid profile;Change in body composition, assessed by bioelectrical impedance analysis (BIA);Change in anthropometric parameters, including body mass index (BMI) and waist circumference | — |
Countries
BR
Contacts
Public ContactLeandro Favaro
Universidade Federal de São Paulo - UNIFESP
Outcome results
None listed