Type 2 DiabetesPhase 4CYP8B1-SGLT2-TNCT07120828
The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity
A Phase 4 study testing Empagliflozin (oral), Dapagliflozin (DAPA) and Metfomin in people with Type 2 Diabetes and Obese Diabetics, run by Erbil Polytechnic University at 1 site in Iraq.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes, Obese Diabetics, Obese Patients (BMI ≥ 30 kg/m²)
- What is being tested?
- Empagliflozin (oral), Dapagliflozin (DAPA) and Metfomin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteIraq
- Study dates
- 15 Jul 2025to 15 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Detailed Description Type 2 Diabetes Mellitus (T2DM) and obesity are major global health burdens with shared pathophysiological mechanisms, including insulin resistance, chronic inflammation, and altered lipid metabolism. SGLT2 inhibitors, such as empagliflozin and dapagliflozin, have emerged as effective glucose-lowering agents that also offer additional benefits, including weight reduction, cardiovascular protection, and renal function preservation.
Despite these advantages, the therapeutic response to SGLT2 inhibitors is variable, often influenced by individual genetic differences. A key genetic determinant is CYP8B1 (cytochrome P450 family 8 subfamily B member 1), a gene encoding sterol 12-alpha-hydroxylase, which regulates bile acid synthesis and lipid metabolism. Polymorphisms in CYP8B1 may impact drug metabolism and alter bile acid-mediated metabolic regulation, potentially affecting both the efficacy and safety profile of SGLT2 inhibitors.
This clinical trial aims to investigate the role of CYP8B1 genetic variations in modifying the clinical and biochemical responses to empagliflozin and dapagliflozin therapy among obese patients recently diagnosed with T2DM.
Participants will be randomized into three groups:
- Group 1: Empagliflozin 10 mg daily
- Group 2: Dapagliflozin 10 mg daily
- Group 3 (Control): Standard care (lifestyle modification and/or metformin)
The intervention period is 6 months, during which multiple parameters will be monitored:
- Obesity-Related Metrics: Body weight, BMI, waist circumference, and body fat percentage.
- Adipokines: adiponectin.
- Lipid Profile: Total cholesterol, HDL, LDL, and triglycerides.
- Glycemic Control: Fasting glucose, HbA1c, and C-peptide.
- Oxidative Stress \& Inflammation
- Ketone Bodies \& Free Fatty Acids: To assess shifts in metabolic fuel utilization.
- Insulin Sensitivity: Using QUICKI and Adipo-IR indices.
- CYP8B1 Genotyping \& Expression: PCR-based genotyping and qPCR-based expression profiling to evaluate genetic and transcriptional regulation. The study integrates molecular genetics (Sanger sequencing and RT-PCR) with clinical biochemistry and metabolic phenotyping to provide a holistic understanding of pharmacogenomic effects. Expected outcomes include:
- Determining whether CYP8B1 polymorphisms influence the degree of weight loss, lipid and glucose metabolism, and adipokine modulation.
- Comparing the efficacy of empagliflozin vs dapagliflozin in the presence of different CYP8B1 genotypes.
- Proposing a framework for personalized T2DM and obesity management based on genetic screening. Study Type Observational Clinical Trial ________________________________________ Study Duration Estimated Study Period: 6 months per participant ________________________________________ Eligibility Criteria Inclusion Criteria:
- Aged ≥18 years
- Newly diagnosed T2DM (<6 months)
- BMI ≥30 kg/m²
- No prior antidiabetic treatment
- Consent to genetic testing Exclusion Criteria:
- Type 1 diabetes or secondary diabetes
- Severe renal impairment (eGFR <45 mL/min/1.73 m²)
- Liver dysfunction or active liver disease
- Pregnancy or lactation
- Allergy to SGLT2 inhibitors Primary Outcome Measures
- Change in body weight and BMI at 6 months
- Genotype-specific differences in weight loss Secondary Outcome Measures
- Changes in adipokine levels
- Lipid profile changes
- HbA1c and fasting blood glucose improvement
- Differences in insulin sensitivity indices
- Expression levels of CYP8B1 mRNA
- Relationship between genotype and biochemical/metabolic outcomes Statistical Analysis Plan
- Paired t-tests and ANOVA for within-group and between-group comparisons
- Genotype-phenotype association using chi-square and regression models
- ROC curve analysis for predicting treatment response
- Cox regression for time-to-event data
- Being tested
- Empagliflozin (oral), Dapagliflozin (DAPA), Metfomin
- Keywords
- CYP8B1, Obese diabetics, oxidative stress
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
MetfominDrug
metformin 500-1000 mg/day administered as part of standard care, based on clinical indication.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin Group | Experimental | 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. Receives: Drug: Empagliflozin (oral) |
| Dapagliflozin Group | Experimental | 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. Receives: Drug: Dapagliflozin (DAPA) |
| Control Group | Active comparator | 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. Receives: Drug: Metfomin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight (kg) from Baseline to 6 Months
Body weight will be measured using a calibrated digital scale at baseline and at 6 months. The change in weight will be calculated by subtracting baseline weight from 6-month weight.
Measured: Baseline and 6 months
Change in Serum Total Cholesterol (mg/dL) from Baseline to 6 Months
Serum total cholesterol will be measured using standard enzymatic methods at baseline and after 6 months. The change will be calculated by subtracting baseline values from follow-up values.
Measured: Baseline to 6 Months
Change in Malondialdehyde (MDA) Levels (µmol/L) from Baseline to 6 Months
Serum MDA will be measured using the TBARS assay to assess lipid peroxidation and oxidative stress.
Measured: Baseline to 6 Months
CYP8B1 Gene Expression Changes
Measure CYP8B1 mRNA expression using real-time PCR to evaluate the relationship between gene expression and treatment response.
Measured: Baseline to 6 Months
Secondary outcomes (14)
Change in Adiponectin Levels
determine changes in serum adiponectin (ng/mL) levels and evaluate their correlation with treatment response and CYP8B1 genotype.
Measured: Baseline to 6 Months
Change in HbA1c
Measure glycated hemoglobin (HbA1c, %) to evaluate the effectiveness of SGLT2 inhibitors in glycemic control in relation to CYP8B1 polymorphisms.
Measured: Baseline to 6 Months
Change in Fasting Blood Glucose
Determine the impact of interventions on fasting glucose levels (mg/dL).
Measured: Baseline to 6 Months
Change in C-Peptide Levels
Evaluate β-cell function by analyzing fasting C-peptide concentrations (ng/mL) pre- and post-treatment.
Measured: Baseline to 6 Months
Change in Blood Ketone Body Levels
Quantify changes in serum ketone levels (mmol/L) to assess shifts in energy metabolism.
Measured: Baseline to 6 Months
Change in Serum HDL Cholesterol (mg/dL) from Baseline to 6 Months
Serum HDL cholesterol will be measured using direct enzymatic assay at baseline and 6 months to evaluate changes in HDL levels.
Measured: Baseline and 6 Months
change in Serum LDL Cholesterol (mg/dL) from Baseline to 6 Months
LDL cholesterol will be calculated using the Friedewald equation , and compared between baseline and 6-month values
Measured: Baseline and 6 Months
Change in Serum Triglycerides (mg/dL) from Baseline to 6 Months
Serum triglyceride levels will be measured enzymatically at baseline and 6 months to assess changes.
Measured: Baseline and 6 Months
Change in Superoxide Dismutase (SOD) Activity (U/mL) from Baseline to 6 Months
SOD enzyme activity will be measured in serum using a colorimetric assay to evaluate antioxidant defense status at baseline and 6 months.
Measured: Baseline and 6 Months
Change in Serum Interleukin-10 (IL-10) Levels (pg/mL) from Baseline to 6 Months
IL-10 will be quantified using a high-sensitivity ELISA kit in serum samples collected at baseline and 6 months.
Measured: Baseline to 6 Months
Change in Glutathione Peroxidase (GPx) Activity (U/mL) from Baseline to 6 Months.
GPx enzyme activity will be measured in serum using a colorimetric assay to evaluate antioxidant defense.
Measured: Baseline to 6 Months
Change in Catalase Activity (U/mL) from Baseline to 6 Months
Catalase activity in serum will be assessed using a spectrophotometric assay to evaluate antioxidant capacity.
Measured: Baseline to 6 Months
Change in Interferon-Gamma (IFN-γ) Levels (pg/mL) from Baseline to 6 Months
Serum IFN-γ levels will be measured using enzyme-linked immunosorbent assay (ELISA) to assess pro-inflammatory status.
Measured: Baseline to 6 Months
Change in Nitric Oxide (NO) Levels (µmol/L) from Baseline to 6 Months
Nitric oxide concentration will be determined in serum using the Griess reaction to evaluate nitrosative stress.
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Jul 2025
- Primary completion30 Aug 2025
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erbil Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Kurdistan Higher Council of Medical Specialties
- Responsible party
- Principal investigator, Ahmed Abdulrazzaq Bapir, Kurdistan Higher Council of Medical Specialties
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120828
- Sponsor's protocol ID
- EPU-CYP8B1-SGLT2-T2DM-2025-01
- Other IDs
- No: 2348524, February 21, 2025
- Acronym
- CYP8B1-SGLT2-T
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected in this study will not be shared due to institutional policies, ethical concerns, and protection of participant confidentiality.
Publications
Scheen AJ. Sodium-glucose cotransporter type 2 inhibitors for the treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2020 Oct;16(10):556-577. doi: 10.1038/s41574-020-0392-2. Epub 2020 Aug 27.
PubMed 32855502Malone JI, Hansen BC. Does obesity cause type 2 diabetes mellitus (T2DM)? Or is it the opposite? Pediatr Diabetes. 2019 Feb;20(1):5-9. doi: 10.1111/pedi.12787. Epub 2018 Nov 5.
PubMed 30311716Klen J, Dolzan V. Treatment Response to SGLT2 Inhibitors: From Clinical Characteristics to Genetic Variations. Int J Mol Sci. 2021 Sep 10;22(18):9800. doi: 10.3390/ijms22189800.
PubMed 34575958Hegyi P, Maleth J, Walters JR, Hofmann AF, Keely SJ. Guts and Gall: Bile Acids in Regulation of Intestinal Epithelial Function in Health and Disease. Physiol Rev. 2018 Oct 1;98(4):1983-2023. doi: 10.1152/physrev.00054.2017.
PubMed 30067158Fioretto P, Zambon A, Rossato M, Busetto L, Vettor R. SGLT2 Inhibitors and the Diabetic Kidney. Diabetes Care. 2016 Aug;39 Suppl 2:S165-71. doi: 10.2337/dcS15-3006.
PubMed 27440829Chiang JYL, Ferrell JM. Bile Acids as Metabolic Regulators and Nutrient Sensors. Annu Rev Nutr. 2019 Aug 21;39:175-200. doi: 10.1146/annurev-nutr-082018-124344. Epub 2019 Apr 24.
PubMed 31018107Chiang JY. Bile acid metabolism and signaling. Compr Physiol. 2013 Jul;3(3):1191-212. doi: 10.1002/cphy.c120023.
PubMed 23897684Sarafidis PA, Tsapas A. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1092. doi: 10.1056/NEJMc1600827. No abstract available.
PubMed 26981941
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity
- ClinicalTrials.gov ID
- NCT07120828
- Acronym / sponsor ID
- CYP8B1-SGLT2-T / EPU-CYP8B1-SGLT2-T2DM-2025-01
- Keywords
- CYP8B1, Obese diabetics, oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Erbil Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Kurdistan Higher Council of Medical Specialties
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Detailed Description Type 2 Diabetes Mellitus (T2DM) and obesity are major global health burdens with shared pathophysiological mechanisms, including insulin resistance, chronic inflammation, and altered lipid metabolism. SGLT2 inhibitors, such as empagliflozin and dapagliflozin, have emerged as effective glucose-lowering agents that also offer additional benefits, including weight reduction, cardiovascular protection, and renal function preservation.
Despite these advantages, the therapeutic response to SGLT2 inhibitors is variable, often influenced by individual genetic differences. A key genetic determinant is CYP8B1 (cytochrome P450 family 8 subfamily B member 1), a gene encoding sterol 12-alpha-hydroxylase, which regulates bile acid synthesis and lipid metabolism. Polymorphisms in CYP8B1 may impact drug metabolism and alter bile acid-mediated metabolic regulation, potentially affecting both the efficacy and safety profile of SGLT2 inhibitors.
This clinical trial aims to investigate the role of CYP8B1 genetic variations in modifying the clinical and biochemical responses to empagliflozin and dapagliflozin therapy among obese patients recently diagnosed with T2DM.
Participants will be randomized into three groups:
- Group 1: Empagliflozin 10 mg daily
- Group 2: Dapagliflozin 10 mg daily
- Group 3 (Control): Standard care (lifestyle modification and/or metformin)
The intervention period is 6 months, during which multiple parameters will be monitored:
- Obesity-Related Metrics: Body weight, BMI, waist circumference, and body fat percentage.
- Adipokines: adiponectin.
- Lipid Profile: Total cholesterol, HDL, LDL, and triglycerides.
- Glycemic Control: Fasting glucose, HbA1c, and C-peptide.
- Oxidative Stress \& Inflammation
- Ketone Bodies \& Free Fatty Acids: To assess shifts in metabolic fuel utilization.
- Insulin Sensitivity: Using QUICKI and Adipo-IR indices.
- CYP8B1 Genotyping \& Expression: PCR-based genotyping and qPCR-based expression profiling to evaluate genetic and transcriptional regulation. The study integrates molecular genetics (Sanger sequencing and RT-PCR) with clinical biochemistry and metabolic phenotyping to provide a holistic understanding of pharmacogenomic effects. Expected outcomes include:
- Determining whether CYP8B1 polymorphisms influence the degree of weight loss, lipid and glucose metabolism, and adipokine modulation.
- Comparing the efficacy of empagliflozin vs dapagliflozin in the presence of different CYP8B1 genotypes.
- Proposing a framework for personalized T2DM and obesity management based on genetic screening. Study Type Observational Clinical Trial ________________________________________ Study Duration Estimated Study Period: 6 months per participant ________________________________________ Eligibility Criteria Inclusion Criteria:
- Aged ≥18 years
- Newly diagnosed T2DM (<6 months)
- BMI ≥30 kg/m²
- No prior antidiabetic treatment
- Consent to genetic testing Exclusion Criteria:
- Type 1 diabetes or secondary diabetes
- Severe renal impairment (eGFR <45 mL/min/1.73 m²)
- Liver dysfunction or active liver disease
- Pregnancy or lactation
- Allergy to SGLT2 inhibitors Primary Outcome Measures
- Change in body weight and BMI at 6 months
- Genotype-specific differences in weight loss Secondary Outcome Measures
- Changes in adipokine levels
- Lipid profile changes
- HbA1c and fasting blood glucose improvement
- Differences in insulin sensitivity indices
- Expression levels of CYP8B1 mRNA
- Relationship between genotype and biochemical/metabolic outcomes Statistical Analysis Plan
- Paired t-tests and ANOVA for within-group and between-group comparisons
- Genotype-phenotype association using chi-square and regression models
- ROC curve analysis for predicting treatment response
- Cox regression for time-to-event data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin Group | Experimental | Drug: Empagliflozin (oral)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. |
| Dapagliflozin Group | Experimental | Drug: Dapagliflozin (DAPA)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. |
| Control Group | Active comparator | Drug: MetfominParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin (oral)Empagliflozin 10 mg oral tablet administered once daily for 6 months. | Drug | Empagliflozin Group |
| Dapagliflozin (DAPA)Dapagliflozin 10 mg oral tablet administered once daily for 6 months | Drug | Dapagliflozin Group |
| Metfominmetformin 500-1000 mg/day administered as part of standard care, based on clinical indication. | Drug | Control Group |
Primary outcome
Change in Body Weight (kg) from Baseline to 6 Months
Time frame: Baseline and 6 months
Body weight will be measured using a calibrated digital scale at baseline and at 6 months. The change in weight will be calculated by subtracting baseline weight from 6-month weight.
Change in Serum Total Cholesterol (mg/dL) from Baseline to 6 Months
Time frame: Baseline to 6 Months
Serum total cholesterol will be measured using standard enzymatic methods at baseline and after 6 months. The change will be calculated by subtracting baseline values from follow-up values.
Change in Malondialdehyde (MDA) Levels (µmol/L) from Baseline to 6 Months
Time frame: Baseline to 6 Months
Serum MDA will be measured using the TBARS assay to assess lipid peroxidation and oxidative stress.
CYP8B1 Gene Expression Changes
Time frame: Baseline to 6 Months
Measure CYP8B1 mRNA expression using real-time PCR to evaluate the relationship between gene expression and treatment response.
14 secondary outcomes
Change in Adiponectin Levels
Time frame: Baseline to 6 Months
Change in HbA1c
Time frame: Baseline to 6 Months
Change in Fasting Blood Glucose
Time frame: Baseline to 6 Months
Change in C-Peptide Levels
Time frame: Baseline to 6 Months
Change in Blood Ketone Body Levels
Time frame: Baseline to 6 Months
Change in Serum HDL Cholesterol (mg/dL) from Baseline to 6 Months
Time frame: Baseline and 6 Months
change in Serum LDL Cholesterol (mg/dL) from Baseline to 6 Months
Time frame: Baseline and 6 Months
Change in Serum Triglycerides (mg/dL) from Baseline to 6 Months
Time frame: Baseline and 6 Months
Change in Superoxide Dismutase (SOD) Activity (U/mL) from Baseline to 6 Months
Time frame: Baseline and 6 Months
Change in Serum Interleukin-10 (IL-10) Levels (pg/mL) from Baseline to 6 Months
Time frame: Baseline to 6 Months
Change in Glutathione Peroxidase (GPx) Activity (U/mL) from Baseline to 6 Months.
Time frame: Baseline to 6 Months
Change in Catalase Activity (U/mL) from Baseline to 6 Months
Time frame: Baseline to 6 Months
Change in Interferon-Gamma (IFN-γ) Levels (pg/mL) from Baseline to 6 Months
Time frame: Baseline to 6 Months
Change in Nitric Oxide (NO) Levels (µmol/L) from Baseline to 6 Months
Time frame: Baseline and 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 32855502Scheen AJ. Sodium-glucose cotransporter type 2 inhibitors for the treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2020 Oct;16(10):556-577. doi: 10.1038/s41574-020-0392-2. Epub 2020 Aug 27.
- Results publication: PubMed 30311716Malone JI, Hansen BC. Does obesity cause type 2 diabetes mellitus (T2DM)? Or is it the opposite? Pediatr Diabetes. 2019 Feb;20(1):5-9. doi: 10.1111/pedi.12787. Epub 2018 Nov 5.
- Results publication: PubMed 34575958Klen J, Dolzan V. Treatment Response to SGLT2 Inhibitors: From Clinical Characteristics to Genetic Variations. Int J Mol Sci. 2021 Sep 10;22(18):9800. doi: 10.3390/ijms22189800.
- Results publication: PubMed 30067158Hegyi P, Maleth J, Walters JR, Hofmann AF, Keely SJ. Guts and Gall: Bile Acids in Regulation of Intestinal Epithelial Function in Health and Disease. Physiol Rev. 2018 Oct 1;98(4):1983-2023. doi: 10.1152/physrev.00054.2017.
- Results publication: PubMed 27440829Fioretto P, Zambon A, Rossato M, Busetto L, Vettor R. SGLT2 Inhibitors and the Diabetic Kidney. Diabetes Care. 2016 Aug;39 Suppl 2:S165-71. doi: 10.2337/dcS15-3006.
- Results publication: PubMed 31018107Chiang JYL, Ferrell JM. Bile Acids as Metabolic Regulators and Nutrient Sensors. Annu Rev Nutr. 2019 Aug 21;39:175-200. doi: 10.1146/annurev-nutr-082018-124344. Epub 2019 Apr 24.
- Results publication: PubMed 23897684Chiang JY. Bile acid metabolism and signaling. Compr Physiol. 2013 Jul;3(3):1191-212. doi: 10.1002/cphy.c120023.
- Results publication: PubMed 26981941Sarafidis PA, Tsapas A. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1092. doi: 10.1056/NEJMc1600827. No abstract available.
- Individual participant dataSharing planned: No. The data collected in this study will not be shared due to institutional policies, ethical concerns, and protection of participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin (oral), Dapagliflozin (DAPA) and Metfomin in people with Type 2 Diabetes and Obese Diabetics, run by Erbil Polytechnic University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (kg) from Baseline to 6 Months (time frame: Baseline and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120828, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.