The Effect of Adding Vildagliptin Versus Glimepiride to Metformin on Markers of Inflammation, Thrombosis, and Atherosclerosis in Diabetic Patients With Symptomatic Coronary Artery Diseases
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in markers of athero-thrombosis and inflammation ( interleukin (IL)-1 beta).
研究概览
简要总结
The aim of this study is to evaluate the effect of adding Vildagliptin versus Glimepiride to Metformin on markers of inflammation, thrombosis, and atherosclerosis in diabetic patients with symptomatic Coronary artery diseases.
The pre-specified established biological markers of inflammation, thrombosis, and atherosclerosis will include: Interleukin 1 beta (IL-1 beta)), hs-CRP, Atherogenic index and coronary risk index, Lipid profile. and adiponectin levels..
详细描述
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).
- All participants agreed to take part in this clinical study and provide informed consent.
- 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.
- Complete physical, laboratory, radiological assessment will be done for all patients to exclude any signs of inflammation or thrombosis.
- Serum samples will be collected for measuring the biomarkers.
- 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.
- All patients will be followed up during 3 months' period.
- At the end of 3 months on the new regimen, steps 4 and 5 will be repeated.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcome: The primary outcome is the change of serum levels of the measured inflammatory markers after 3 months.
- Results, conclusion, discussion and recommendations will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with Type II-diabetes mellitus on metformin who are planned to be managed with vildagliptin or glimepiride plus metformin at the time of inclusion.
- •Symptomatic Coronary Artery Diseases. (>30 days).
排除标准
- •Hepatic impairment.
- •Active malignancy.
- •Planned surgical intervention.
- •Any signs of hypersensitivity or contraindication to study drugs developed.
- •Any patient with any signs of active infection or thrombosis at the time of assessment.
- •Addition of any antidiabetic medications or insulin during follows up.
- •Chronic inflammatory disease (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
- •Clinically advanced congestive heart failure - New York Heart Association III-IV
- •Severe left ventricular dysfunction (LVEF<30%) with New York Heart Association II or any New York Heart Association class with documented recent heart failure decompensation (<3 months)
- •Severe stable cardiac angina Community Competence Scale III - IV or Unstable angina
- •Pregnancy, lactation or child-bearing potential.
研究组 & 干预措施
vildagliptin / metformin
Group I (n=40) are patients who are taking vildagliptin 50 mg oral tablet plus their metformin1000 mg oral tablet to control their blood sugar level.
干预措施: Vildagliptin 50 mg Oral Tablet (Drug)
vildagliptin / metformin
Group I (n=40) are patients who are taking vildagliptin 50 mg oral tablet plus their metformin1000 mg oral tablet to control their blood sugar level.
干预措施: Metformin 1000 mg Oral Tablet (Drug)
glimepiride / metformin.
Group II (n=40) are patients who are taking Glimepiride 4 mg oral tablet plus their metformin1000 mg oral tablet to control their blood sugar level.
干预措施: Metformin 1000 mg Oral Tablet (Drug)
glimepiride / metformin.
Group II (n=40) are patients who are taking Glimepiride 4 mg oral tablet plus their metformin1000 mg oral tablet to control their blood sugar level.
干预措施: Glimepiride upto 4 mg Oral Tablet (Drug)
结局指标
主要结局
Change in markers of athero-thrombosis and inflammation ( interleukin (IL)-1 beta).
时间窗: Baseline and 3 months
A-Change in interleukin (IL)-1 beta (IL-1ß) level will be determined by Enzyme-linked immunosorbent assay (ELISA). (unit: Picogram/milliliter pg/ml).
Change in Adiponectin level.
时间窗: Baseline and 3 months
A- Adiponectin level will be determined by Enzyme-linked immunosorbent assay (ELISA)..(unit: mg/L)
Change in High sensitivity C-reactive protein (hsCRP) level.
时间窗: Baseline and 3 months
A- High sensitivity C-reactive protein (hsCRP) level will be determined by nephelometric procedure.(unit: mg/L)
次要结局
- Percent Change in ( Low-density lipoprotein (LDL) cholesterol / High-density lipoprotein (HDL) cholesterol ) for each patient before and after 3 months combination treatment for each group .(Baseline and 3 months)
- Change in Lipid profile(Baseline and 3 months)
- Change in Hemoglobin A1c (HbA1c).(Baseline and 3 months)
- Percent Change in (total cholesterol / High-density lipoprotein (HDL) cholesterol) for each patient before and after 3 months combination treatment for each group .(Baseline and 3 months)
研究者
Rehab Werida
Principal Investigator
Damanhour University