At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity
In Brief
A Phase 4 clinical trial evaluating Empagliflozin (oral), Dapagliflozin (DAPA), and 1 other intervention for Type 2 Diabetes and 2 related conditions. Completed, enrolled 260 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
Empagliflozin 10 mg oral tablet administered once daily for 6 months.
Dapagliflozin 10 mg oral tablet administered once daily for 6 months
metformin 500-1000 mg/day administered as part of standard care, based on clinical indication.