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The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity

ClinicalTrials.gov · COMPLETED, 2026

260 participants

Abstract

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

Conditions: Type 2 Diabetes, Obese Diabetics, Obese Patients (BMI ≥ 30 kg/m²).

Primary outcome: Change in Body Weight (kg) from Baseline to 6 Months; Change in Serum Total Cholesterol (mg/dL) from Baseline to 6 Months; Change in Malondialdehyde (MDA) Levels (µmol/L) from Baseline to 6 Months; CYP8B1 Gene Expression Changes.

Enrollment: 260 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 260 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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