Effect of Adding Vildagliptin vs Glimepiride to Metformin on Inflammation's Markers in Type-2 Diabetic Patients With CAD

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
The study is designed as a single‐center, randomized, double‐blinded, clinical trial to provide evidence on the effects of vildagliptin on key biomarkers of atherothrombosis and inflammation. The investigators plan to prospectively enroll 80 patients with proven coronary artery disease ,Diabetes type2 and randomize them in a 1:1 ratio to either vildagliptin‐metformin therapy (n=40) or glimepiride /metformin therapy (n=40). 1. All participants agreed to take part in this clinical study and provide informed consent. 2. Patients with Coronary artery diseases.and uncontrolled Diabetes type2 who's taking metformin only will be enrolled (n=80) from endocrinology clinic at Alexandria Armed Forces hospital. 3. Complete physical, laboratory, radiological assessment will be done for all patients to exclude any signs of inflammation or thrombosis. 4. Serum samples will be collected for measuring the biomarkers. 5. All enrolled patients will be mentioned as two groups; Group I (n=40) are patients who the endocrinologist prescribed them vildagliptin plus their metformin to control their blood sugar level. Group II (n=40) are patients who the endocrinologist prescribed them glimepiride plus their metformin. 6. All patients will be followed up during 3 months' period. 7. At the end of 3 months on the new regimen, steps 4 and 5 will be repeated. 8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9. Measuring outcome: The primary outcome is the change of serum levels of the measured inflammatory markers after 3 months. 10. Results, conclusion, discussion and recommendations will be given.
Epistemonikos ID: 35f3c450057bc5c84501b64f55ba24f3b4319822
First added on: May 21, 2024