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

RECRUITINGPhase 4Sponsored by Erbil Polytechnic University
Actively Recruiting
PhasePhase 4
SponsorErbil Polytechnic University
Started2025-07-15
Est. completion2026-03-01
Eligibility
Age40 Years+
Healthy vol.Accepted

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

Age: 40 Years+Healthy volunteers accepted
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

DiabetesObese DiabeticsObese Patients (BMI ≥ 30 kg/m²)Type 2 Diabetes

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