Type 2 diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: In Intervention Group 1, which involves combination therapy with empagliflozin and metformin, patients with type 2 diabetes who have been on stable-dose metformin therapy for at least
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 on stable-dose metformin monotherapy for the past 3 months, with no changes in the type or dose of antidiabetic medications, yet with blood glucose levels still outside the target range (metformin resistance) and hemoglobin A1c levels between 7.5–8.5%.
Exclusion criteria
Exclusion criteria: Blindness caused by type 2 diabetes complications Requirement for dialysis due to type 2 diabetes complications History of severe stroke caused by type 2 diabetes complications Hemolytic anemia Hemoglobinopathies Concurrent use of antioxidant drugs Patients with thyroid disorders Concurrent use of anti-inflammatory drugs Having a medical history of dementia Having a medical history of Alzheimer's disease Uncontrolled hypertension more than 180/110 millimeters of mercury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean serum Adropin levels. Timepoint: The mean serum adropin level will be measured before the intervention and 12 weeks after the completion of the intervention. Method of measurement: The blood test using the ELISA method.;Mean change in insulin resistance. Timepoint: The mean changes in insulin resistance will be measured before the intervention and 12 weeks after the completion of the intervention. Method of measurement: Blood test using ELISA kit (HOMA-IR index). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in fasting blood glucose levels. Timepoint: The mean changes in fasting blood sugar will be measured before the intervention and 12 weeks after the completion of the intervention. Method of measurement: The blood test will be performed using a glucometer.;Mean change in glycated hemoglobin. Timepoint: The mean changes in glycosylated hemoglobin will be measured before the intervention and 12 weeks after the completion of the intervention. Method of measurement: Blood test-measured by high-performance liquid chromatography/HPLC.;Mean change in serum triglyceride levels. Timepoint: The mean changes in serum triglyceride levels will be measured before the intervention and 12 weeks after the completion of the intervention. Method of measurement: Blood test- measured by enzymatic method.;Mean change in serum total cholesterol levels. Timepoint: The mean changes in serum total cholesterol levels will be measured before the intervention and 12 weeks after the completion of the intervention. Method of measurement: Blood test- measured by enzymatic method.;Mean change in serum HDL levels. Timepoint: The mean changes in serum HDL levels will be measured before the intervention and 12 weeks after the completion of the intervention. Method of measurement: Blood test- measured by enzymatic method.;Mean change in serum LDL levels. Timepoint: The mean changes in serum LDL levels will be measured before the intervention and 12 weeks after the completion of the intervention. Method of measurement: Blood test- measured by enzymatic method.;Mean change in body mass index (kg/m²). Timepoint: The mean changes in serum body mass index will be measured before the intervention and 12 weeks after the completion of the 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