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

Study on Diabetes Drugs and Gene Activity in Obese Patients

NCT: NCT07120828 · Status: COMPLETED · Phase: Phase 4 · Sponsor: Erbil Polytechnic University · Started: 2025-07-15 · Est. Completion: 2026-03-15

Plain English Summary

The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity is a Phase 4 clinical trial sponsored by Erbil Polytechnic University studying Type 2 Diabetes, Obese Diabetics, Obese Patients (BMI ≥ 30 kg/m²). This study tests how two diabetes medications, dapagliflozin and empagliflozin, affect gene activity and body markers in obese patients with Type 2 Diabetes. It is for adults newly diagnosed with Type 2 Diabetes who are also obese and have not taken these specific diabetes medications before. Participants will take one of the study medications (dapagliflozin, empagliflozin) or metformin daily for 6 months, with regular check-ups and blood tests. Alternatives include standard diabetes care with metformin, or other diabetes medications not part of this study. The trial aims to enroll 260 participants.

Official 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

Here is what you need to know about eligibility for this trial. You can join if you are newly diagnosed with Type 2 Diabetes (within 6 months) and have a BMI of 30 or higher. You cannot join if you have Type 1 diabetes, severe kidney problems, liver disease, are pregnant or breastfeeding, or have had a bad reaction to SGLT2 inhibitors. Participants must be willing to follow study instructions and attend all appointments. The study is for adults, and specific age ranges are not detailed but generally implies adult participation. This trial is studying Type 2 Diabetes, Obese Diabetics, Obese Patients (BMI ≥ 30 kg/m²), so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure changes in body weight, cholesterol, and a marker of cell damage, indicating how effectively the drugs might improve overall metabolic health and reduce harmful processes The specific primary outcome measures are: Change in Body Weight (kg) from Baseline to 6 Months (Baseline and 6 months); Change in Serum Total Cholesterol (mg/dL) from Baseline to 6 Months (Baseline to 6 Months); Change in Malondialdehyde (MDA) Levels (µmol/L) from Baseline to 6 Months (Baseline to 6 Months); CYP8B1 Gene Expression Changes (Baseline to 6 Months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial matters because it seeks to understand how certain diabetes medications impact the body's metabolism and inflammation at a genetic level, potentially leading to better treatment strategies This research targets Type 2 Diabetes, Obese Diabetics, Obese Patients (BMI ≥ 30 kg/m²), where improved treatment options are needed.

Investor Insight

This Phase 4 study, sponsored by a university, investigates established drugs, suggesting a focus on understanding mechanisms rather than discovering new treatments, with a moderate investment signal This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor if this study is right for you, especially regarding your current health and any other medications you take. Participation involves taking a study medication daily for 6 months and attending regular clinic visits for check-ups and tests. You will need to provide blood samples and have your weight and cholesterol monitored throughout the study. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07120828?

NCT07120828 is a Phase 4 INTERVENTIONAL study titled "The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity." It is currently completed and is sponsored by Erbil Polytechnic University. The trial targets enrollment of 260 participants.

What conditions does NCT07120828 study?

This trial investigates treatments for Type 2 Diabetes, Obese Diabetics, Obese Patients (BMI ≥ 30 kg/m²). The primary condition under study is Type 2 Diabetes.

What treatments are being tested in NCT07120828?

The interventions being studied include: Empagliflozin (oral) (DRUG), Dapagliflozin (DAPA) (DRUG), Metfomin (DRUG). Empagliflozin 10 mg oral tablet administered once daily for 6 months.

What does Phase 4 mean for NCT07120828?

Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.

What is the current status of NCT07120828?

This trial is currently "Completed." It started on 2025-07-15. The estimated completion date is 2026-03-15.

Who is sponsoring NCT07120828?

NCT07120828 is sponsored by Erbil Polytechnic University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07120828?

The trial aims to enroll 260 participants. The trial status is completed.

How is NCT07120828 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07120828?

The primary outcome measures are: Change in Body Weight (kg) from Baseline to 6 Months (Baseline and 6 months); Change in Serum Total Cholesterol (mg/dL) from Baseline to 6 Months (Baseline to 6 Months); Change in Malondialdehyde (MDA) Levels (µmol/L) from Baseline to 6 Months (Baseline to 6 Months); CYP8B1 Gene Expression Changes (Baseline to 6 Months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07120828 being conducted?

This trial is being conducted at 1 site, including Erbil, Kurdistan (Iraq).

Where can I find official information about NCT07120828?

The official record for NCT07120828 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07120828. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07120828 testing in simple terms?

This study tests how two diabetes medications, dapagliflozin and empagliflozin, affect gene activity and body markers in obese patients with Type 2 Diabetes. It is for adults newly diagnosed with Type 2 Diabetes who are also obese and have not taken these specific diabetes medications before.

Why is this trial significant?

This trial matters because it seeks to understand how certain diabetes medications impact the body's metabolism and inflammation at a genetic level, potentially leading to better treatment strategies

What are the potential risks of participating in NCT07120828?

Common side effects of these types of diabetes medications can include urinary tract infections and yeast infections. Potential risks include changes in kidney function, dehydration, and very rarely, serious allergic reactions. As this is a Phase 4 study, the risks are generally well-understood from prior research on these drugs. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07120828?

Ask your doctor if this study is right for you, especially regarding your current health and any other medications you take. Participation involves taking a study medication daily for 6 months and attending regular clinic visits for check-ups and tests. You will need to provide blood samples and have your weight and cholesterol monitored throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07120828 signal from an investment perspective?

This Phase 4 study, sponsored by a university, investigates established drugs, suggesting a focus on understanding mechanisms rather than discovering new treatments, with a moderate investment signal This is a Phase 4 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will take one of the study medications (dapagliflozin, empagliflozin) or metformin daily for 6 months, with regular check-ups and blood tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.