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

Plain-language summary

This study examines the role of CYP8B1 gene polymorphisms in the biochemical pathways affected by the SGLT2 inhibitor drugs (Empagliflozin, Dapagliflozin) and Metformin in patients with type 2 diabetes and obesity. Newly diagnosed patients with a body mass index of 30 or higher who had not previously used diabetes medication could take part. The study was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Erbil Polytechnic University

Intervention

Empagliflozin (oral), Dapagliflozin (DAPA), Metfomin

Start date

7/15/2025

Estimated completion

3/15/2026

Countries

Iraq

Related genes

Locations

• Erbil, Iraq

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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.