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

Sponsor
Erbil Polytechnic University
Study ID
NCT07120828
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin (oral) — DRUG
    Empagliflozin 10 mg oral tablet administered once daily for 6 months.
  • Dapagliflozin (DAPA) — DRUG
    Dapagliflozin 10 mg oral tablet administered once daily for 6 months
  • Metfomin — DRUG
    metformin 500-1000 mg/day administered as part of standard care, based on clinical indication.

Study Details

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

Key Dates

Start date
Jul 15, 2025
Status verified
Mar 2026
Primary completion
Aug 30, 2025
Completion
Mar 15, 2026

Study Design

Enrollment
260 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Body Weight (kg) from Baseline to 6 Months [ Time Frame: Baseline and 6 months ]

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