The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibit… (NCT07120828) | Clinical Trial Compass
CompletedPhase 4
The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity
Iraq260 participantsStarted 2025-07-15
Plain-language 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
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Body Weight (kg) from Baseline to 6 Months
Timeframe: Baseline and 6 months
2
Change in Serum Total Cholesterol (mg/dL) from Baseline to 6 Months
Timeframe: Baseline to 6 Months
3
Change in Malondialdehyde (MDA) Levels (µmol/L) from Baseline to 6 Months