NCT05429554Unknown不适用
The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and Cardiovascular Protection in Type 2 Diabetic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- improve the neurodegeneration and cardiovascular effect in diabetic patients
研究概览
简要总结
The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients
详细描述
This study aims to investigate the effect of daily oral DPP4 inhibitors and oral metformin on neurodegeneration in type 2 diabetic patients.
This study aims to compare between the cardiovascular protective properties of DPP-4 inhibitors and Metformin in type 2 diabetic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient should be diagnosed with Type 2 diabetes mellitus (T2DM) and guided with HA1c ≥7, age ≥40 years.
- •moderate hypertension.
排除标准
- •• Diabetic patients who have been currently receiving anti-diabetic agents other than metformin and/or insulin
- •Patients with type 1 DM, active liver disease, recent history of cardiovascular disease (acute coronary syndrome, coronary artery intervention, New York Heart Association Class III/IV heart failure, stroke, transient ischemic neurologic event, or new/worsening symptoms of coronary heart disease or cerebrovascular disease), severe peripheral vascular disease, triglyceride levels ≥ 600 mg/dL, history of HIV infection, pancreatitis, malignancy or clinically important hematologic disorder, and an estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease formula) less than 30 mL/min/1.73 m
- •Moreover, patients with dementia, AD, those were in delirium status during evaluation period, patients with psychotic disease (schizoaffective disorder, etc.)
- •Alcohol and substance addiction were not enrolled in the study.
- •Also, patients who have any hypersensitivity to metformin or to DPP4 inhibitors were also excluded.
研究组 & 干预措施
group 1
patients will be treated with DPP4 inhibitor + metformin
干预措施: Vildagliptin (Drug)
结局指标
主要结局
improve the neurodegeneration and cardiovascular effect in diabetic patients
时间窗: September 2022
improve the cognition and cardiovascular effect in type 2 diabetic patients
次要结局
未报告次要终点
研究者
Toka Hesham
Teaching assistant of Clinical Pharmacy
MTI University
研究点 (1)
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