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临床试验/CTRI/2024/08/072736
CTRI/2024/08/072736尚未招募不适用

A Comparative Cross-Sectional Study on Coagulation and Platelet Parameters in Type 2 Diabetic Patients and Non-Diabetic Individuals at a Tertiary Care Hospital

AIIMS RAJKOT1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
All cause coagulation parameter

研究概览

简要总结

1.    A significant issue for global health is diabetes mellitus (DM). In the world, type 2 diabetes, which is characterized by insulin resistance, accounts for 90% of cases .With 80% of DM patients dying from thrombotic causes and 75% of these fatalities coming from cardiovascular problems, people with DM have a high risk of atherothrombotic events. The incidence and prevalence of DM are rapidly increasing, making it one of the most common and expensive chronic diseases in the world.

Due to its 2- to 4-fold increase in the risk of peripheral artery disease, coronary heart disease, and stroke, atherothrombosis is the primary cause of morbidity and mortality in diabetes.Eighty percent of patients with DM died from thrombotic complications, with cardiovascular problems accounting for 75 percent of these deaths. Endothelial dysfunction, platelet hyperactivation, reactive oxygen species cause endothelial dysfunction, and enhanced activation of pro-thrombotic coagulation factors along with reduced fibrinolysis are the pathophysiological mechanisms linked to the diabetic pro-thrombotic state.

Diabetes involves various factors such as hyperglycemia, insulin resistance, insulin insufficiency, cellular abnormalities, metabolic problem, inflammation, and oxidative stress. These factors contribute to the dysregulation of multiple signaling pathways, which in turn stimulate platelet increased adhesion, activation, and aggregation. Research has demonstrated that the presence of hyperglycemia leads to an increase in platelet size and hyperactivation. Consequently, platelets of greater size exhibit a heightened release of prothrombotic substances, including thromboxane A2.

Hematological indicators that provide information on the coagulation status include fibrinogen, prothrombin time, and activated partial thromboplastin time. Relevant indicators that might indicate the quantity, size, and activity of platelets include platelet count and platelet indices . Therefore, the purpose of this study is to evaluate the platelet parameter and coagulation status of type II diabetic patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • (1) Diagnosed Individual of type 2 diabetes of either sex presented to OPD or IPD of age group 18-65 years (2) Healthy control individual without type 2 diabetes of either sex presented to OPD or IPD of age group 18-65 years.

排除标准

  • (1) Type 1 DM (2) History of thromboembolism (3) Individual on anti-platelet or anti coagulation therapy or on Oral contraceptive (4) Inherited knowns case of coagulation disorder (5) Pregnant women (6) Undergone any operation in last few weeks (7) Known chronic liver disease.

结局指标

主要结局

All cause coagulation parameter

时间窗: At 8 weeks

次要结局

  • All cause platelet parameters(2 years)

研究者

发起方
AIIMS RAJKOT
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Parth Rajendragiri Goswami

AIIMS Rajkot

研究点 (1)

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