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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Iraq
Epu
RECRUITING
Erbil
Contact Information
Primary
ahmed Bapir, pHD
ahmed.mhm20@epu.edu.iq
009647507580043
Backup
Goran Othman, PHD
goran.othman@epu.edu.iq
+9647504492631
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 260
Treatments
Experimental: Empagliflozin Group
Participants in this group will receive empagliflozin 10 mg orally once daily for a duration of 6 months. The intervention aims to evaluate the effect of empagliflozin on weight reduction, metabolic parameters, and biochemical outcomes in newly diagnosed obese T2DM patients, with a focus on the influence of CYP8B1 polymorphisms on treatment response.
Experimental: Dapagliflozin Group
Participants in this group will receive dapagliflozin 10 mg orally once daily for a duration of 6 months. This arm is designed to assess the clinical and biochemical effects of dapagliflozin, particularly regarding changes in adipokines, lipid profile, insulin sensitivity, and the impact of CYP8B1 genetic variations.
Active_comparator: Control Group
Participants in this group will receive standard care, including dietary and lifestyle modifications and metformin therapy if clinically indicated, according to ADA guidelines. This arm will serve as a comparator to evaluate the relative efficacy of SGLT2 inhibitors and the role of CYP8B1 polymorphisms in treatment outcomes.
Related Therapeutic Areas
Sponsors
Collaborators: Kurdistan Higher Council of Medical Specialties
Leads: Erbil Polytechnic University

This content was sourced from clinicaltrials.gov