跳至主要内容
临床试验/CTRI/2025/09/095013
CTRI/2025/09/095013招募中不适用

Effect of Glycemic Control on Platelet Parameters In Children And Adolescents With Type 1 Diabetes– A Case Control Study

Government Institute of Medical Sciences Greater Noida1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年10月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
To determine the correlation between glycemic control (HbA1c level) and

研究概览

简要总结

Type 1 diabetes mellitus (T1DM) is an autoimmune endocrine metabolic disorder. It is caused by the destruction of pancreatic beta cells, triggered by genetic and environmental factors. The incidence of Type 1 diabetes mellitus (T1DM) is increasing day by day and associated with multiple complications in children and adolescents due to its prothrombotic state [1]. As the onset of disease occurs in early life, the affected group of individuals are at a great risk of developing cardiovascular risk as a complication of diabetes. Over time, the various vascular complications arise from hyperglycemia, dyslipidemia, inflammation, and oxidative stress and depends on the duration of diabetes, level of metabolic control, and genetic factors. Glycemic variability and long-term hyperglycemia contribute significantly to increased morbidity and mortality. T1DM is associated with altered metabolic environment which causes platelet dysfunction and morphological changes, leading to thrombus formation and increased risk of coronary and thromboembolic events [2]. In diabetic diseases, changes in the levels of a wide range of haematological parameters function and morphology have been highlighted in studies [3]. The complete blood count is a cheap and rapid test, and the hematological indices in this test can be used to predict various vascular complications due to endothelial dysfunction and inflammation.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Children and Adolescents(5-18yrs) diagnosed with T1DM with duration more than 6 months, being followed up in the department of Pediatrics attending the diabetic clinic will be included in the study
  • Patients who would be willing to give informed consent.

排除标准

  • Children who are not diagnosed with Type 1 DM and are routinely visiting department of Pediatrics for health checkups and other OPDs like Surgery/ ENT/ Ophthalmology for minor procedures or follow up will be enrolled as control • Patients who would be willing to give informed consent.

结局指标

主要结局

To determine the correlation between glycemic control (HbA1c level) and

时间窗: at the time of Enrollment day 1

platelet parameters in children and adolescents with type 1 Diabetes Mellitus

时间窗: at the time of Enrollment day 1

次要结局

  • • To compare platelet parameters between children & adolescents with Type1(Diabetes Mellitus (cases) & age-matched healthy controls)

研究者

发起方
Government Institute of Medical Sciences Greater Noida
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rakesh Gupta

Government Institute of Medical Sciences (GIMS)

研究点 (1)

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