Type 2 diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group 1 (Empagliflozin + Metformin Group):In the first group, patients with type 2 diabetes who failed to achieve adequate glycemic control (HbA1c 7.5-8.5%) despite at lea
Sponsors
Sanandaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Iranian nationality Diagnosed with type 2 diabetes for a minimum of 6 months and a maximum of 10 years Body mass index greater than or equal to 25 No acute illness in the past 6 months Patients must have been on stable-dose metformin monotherapy for the past 3 months, yet their blood glucose remains uncontrolled (outside target range), demonstrating metformin resistance, with hemoglobin A1c levels between 7.5-8.5%
Exclusion criteria
Exclusion criteria: Development of type 2 diabetes complications that disrupt care (e.g., blindness, dialysis, severe stroke) Medical history of cognitive disorders (e.g., dementia, Alzheimer’s) Uncontrolled hypertension more than 180/110 millimeters of mercury Hemolytic anemia Hemoglobinopathies Any change in type/dose of prescribed diabetes medications during the 3-month study period Patients with a history of fatty liver disease Concurrent use of antioxidant or anti-inflammatory drugs Patients with thyroid disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean serum fetuin-A level. Timepoint: Serum fetuin-A levels will be measured before the intervention and at week 12. Method of measurement: The blood test using the ELISA method.;Mean change in insulin resistance. Timepoint: Mean change in insulin resistance will be measured before the intervention and at week 12. Method of measurement: Blood test using ELISA kit (HOMA-IR index). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in fasting blood glucose levels. Timepoint: Mean change in fasting blood glucose levels will be measured before the intervention and week 12 post-intervention. Method of measurement: The blood test will be performed using a glucometer.;Mean change in glycated hemoglobin. Timepoint: Mean change in glycated hemoglobin will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test-measured by high-performance liquid chromatography/HPLC.;Mean change in serum triglyceride levels. Timepoint: Mean change in serum triglyceride levels will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test- measured by enzymatic method.;Mean change in serum total cholesterol levels. Timepoint: Mean change in serum total cholesterol levels will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test- measured by enzymatic method.;Mean change in serum HDL levels. Timepoint: Mean change in serum HDL levels will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test- measured by enzymatic method.;Mean change in serum LDL levels. Timepoint: Mean change in serum LDL levels will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Blood test- measured by enzymatic method.;Mean change in body mass index (kg/m²). Timepoint: Mean change in body mass index will be measured before the intervention and 12 weeks post-intervention. Method of measurement: Measurements will be performed by trained staff using calibrated digital scales (accuracy 0.1 kg) and standard stadiometers (accuracy 0.5 cm). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Golnaz Azami
Sanandaj University of Medical Sciences
Outcome results
None listed