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临床试验/NCT06676683
NCT06676683尚未招募不适用

The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease in a Low Income Community

Sohag University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年12月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
changes in lipid profile in response to treatment with statin in diabetc patients

研究概览

简要总结

the use of Statin in diabetic patients and its correlation to the guidelines recommendation.

详细描述

Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by hyperglycemia due to insulin resistance resulting in vascular complications. It accounts for approximately 75% of all atherosclerosis-related events.

Moreover, 65% of patients with diabetes die from any type of cardiovascular disease or stroke. Currently, lipid-lowering statin therapy is recommended for the primary prevention of atherosclerotic cardiovascular diseases, as well as for secondary prevention in DM patients with established cardiovascular disease.

The cardiovascular effects of statins extend beyond their effects on lipid fractions and include atherosclerotic plaque stabilization, anti-inflammatory effects, inhibition of vascular smooth muscle cell proliferation, inhibition of platelet function, and improved vascular endothelial function.

Diabetes mellitus (DM) increases cardiovascular disease (CVD) incidence and mortality. While guidelines endorse statin use in type 2 DM (T2DM) to mitigate cardiovascular risks and mortality, challenges like statin initiation and prompt treatment adjustments affect patient outcomes.

According to the ADA and ACC/AHA guidelines, moderate-intensity statin and lifestyle modifcations are recommended for all diabetic patients aged 40-75 without contraindication to statin therapy to achieve an LDL goal of less than 100 mg/dL. Furthermore, high-intensity statin therapy is recommended for patients with cardiovascular risk factors or overt cardiovascular disease to achieve the LDL goal of less than 70 mg/day.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All diabetic > 18 years.

排除标准

  • Diabetic Patients with known to have Atherosclerotic cardiovascular disease.

结局指标

主要结局

changes in lipid profile in response to treatment with statin in diabetc patients

时间窗: 12 Weeks

Guidelines endorse statin use in Type 2 Diabetes Mellitus (T2DM) to mitigate cardiovascular risks and mortality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Islam Abd El-aziz Hassan Mahmoud

Doctor

Sohag University

研究点 (1)

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