NCT07120828CompletedPhase 4
The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 31 Jul 2025
- Start date
- 15 Jul 2025
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Erbil Polytechnic University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07120828
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 260
- From 15 Jul 2025 to the primary completion date, 30 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History or diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes.
- Active liver disease or significant hepatic dysfunction.
- 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.
Lab values
- Estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/1.73 m² (moderate to severe renal impairment).
Other
- Current pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Epu Coordinator of this site? Confirm its status | Erbil | Iraq | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.