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临床试验/CTRI/2022/08/044536
CTRI/2022/08/044536尚未招募不适用

Evaluation of cardiovascular disease risk in type 2 diabetes mellitus patients using framingham risk score, qrisk3, interheart risk scores and their correlation with lipoprotein (a) level.

Dr Ramesh Kumar Chandak1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2022年8月8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
89
试验地点
1
主要终点
To assess CVD risk in patients of type 2 Diabetes mellitus using various risk scores- FRS,Q RISK 3 ,and Interheart risk score.

研究概览

简要总结

Cardiovasculardiseases (CVDs) are the single leading cause of death globally.Diabetes elevates the risk for cardiovascular disease (CVD) complications,particularly atherosclerotic vascular disease. Cardiovascular events remain themajor cause of death for those with diabetes, accounting for about 70% of alldeaths in the patient population.

Lipoprotein (a)is a low-density lipoprotein (LDL) particle with the glycoprotein apo(a) covalentlybound to apo B-100. Apo(a) is a highly glycosylated hydrophilic apolipoproteinwhich is synthesized by the liver. Apo(a) is structurally homologous to theplasma protein plasminogen which is involved in the lysis of clots.Strong evidence in epidemiological, genetic, and prospective cohort studiesverified that circulating lp(a) levels were associated with the presence ofcardiovascular disease (CVD). Lipoprotein (a) is an emergingcardiovascular risk factor which is also associated with diabetes.

In the presentstudy CVD risk in type 2 diabetes will be assessed and categorized into thoseat   low, moderate, and high CVD risk bycalculating various risk scores methods that are: 17

(1) FRAMINGHAMRISK SCORE

(2) QRISK3

(3) INTERHEARTRISK SCORE

Hospital basedcross sectional study will be carried out in Department of Biochemistry of RUHSCollege of Medical Sciences & associated hospital, Jaipur, over a period of1.5 years. 90 participants of either gender with type 2 DM will be recruited attendingmedicine OPD and IPD  after writteninformed consent and ethics approval from the institutional ethics committee. normal distribution=1.96, absoluteprecision =9% prevalence =25% so so sample size will be taken approximate  90. and in this study patients will be included 30 to 70 years age of either gender of type 2 diabetes mellitus .

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • With or Without Microvascular Complications of type 2 DM.

排除标准

  • 1Previous history of CVD.
  • 2Patients with macrovascular complications of diabetes.
  • 3Terminally ill.
  • 4Severe liver and renal insufficiency.
  • 5Type 1 DM 6Cancer.
  • 7Thyroid dysfunctions.
  • 8Severe mental illness.
  • 9Pregnancy.
  • 10Peripheral artery disease.
  • 11Hemolytic disease.
  • 12Fever & goiter.
  • 13Sleep apnea syndrome.
  • 14Severe disabilities.

结局指标

主要结局

To assess CVD risk in patients of type 2 Diabetes mellitus using various risk scores- FRS,Q RISK 3 ,and Interheart risk score.

时间窗: 6 months

次要结局

  • to assess lipoprotein a and compare anthropometric parameters in type 2 DM patients(3 months)

研究者

发起方
Dr Ramesh Kumar Chandak
申办方类型
Other []

研究点 (1)

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