The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity
NCT07120828
Summary
This study explores the long-term effects of dapagliflozin and empagliflozin on CYP8B1 gene expression and a range of metabolic, oxidative, and inflammatory biomarkers in obese patients with Type 2 Diabetes Mellitus (T2DM). Over a 6-month period, participants are assigned to three treatment arms: metformin (control), dapagliflozin, and empagliflozin. The study aims to determine how these medications influence bile acid metabolism, oxidative stress, leptin, GLP-1, IL-10, and IFN-γ, providing insight into the broader metabolic benefits of SGLT2 inhibitors
Eligibility
Inclusion Criteria: * Newly diagnosed with Type 2 Diabetes Mellitus (within the past 6 months). * Body Mass Index (BMI) ≥ 30 kg/m² (classified as obese). * No prior treatment with SGLT2 inhibitors or other antidiabetic medications. * Willing and able to provide written informed consent. * Able to comply with study visits, procedures, and sample collection. Exclusion Criteria: * History or diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes. * Estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/1.73 m² (moderate to severe renal impairment). * Active liver disease or significant hepatic dysfunction. * Current pregnancy or breastfeeding. * Known hypersensitivity or contraindication to SGLT2 inhibitors. * hypertension * Any other condition that, in the opinion of the investigator, may interfere with the patient's ability to complete the study or pose additional risk.
Conditions4
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NCT07120828