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

NCT07120828 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-03-17

No results posted yet for this study

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

Conditions

Interventions

DRUG

Empagliflozin (oral)

Empagliflozin 10 mg oral tablet administered once daily for 6 months.

DRUG

Dapagliflozin (DAPA)

Dapagliflozin 10 mg oral tablet administered once daily for 6 months

DRUG

Metfomin

metformin 500-1000 mg/day administered as part of standard care, based on clinical indication.

Sponsors & Collaborators

  • Kurdistan Higher Council of Medical Specialties

    collaborator OTHER

  • Erbil Polytechnic University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2025-08-30
Completion
2026-03-15

Countries

  • Iraq

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120828 on ClinicalTrials.gov