跳至主要内容
临床试验/CTRI/2023/11/060073
CTRI/2023/11/060073已完成不适用

Correlation between dyslipidemia and Left Ventricular Diastolic dysfunction in Newly detected Asymptomatic Type 2 Diabetes Mellitus

Dr Gundeti Nikhil1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
To study the prevalence of left ventricular diastolic dysfunction in asymptomatic newly detected type 2 Diabetes mellitus.

研究概览

简要总结

NEED FOR THE STUDY

The left ventricular diastolic dysfunction represents the earliest pre-clinical manifestation of diabetic cardiomyopathy, preceding the systolic dysfunction and being able to evolve to symptomatic heart failure

Accordingly, it is highly recommended to perform early detection and management of myocardial dysfunction in the diabetic population before the development of overt HF.

DESCRIPTION

Newly diagnosed diabetic patients based on study inclusion and exclusion criteria are selected and explained about the study and enrolled after giving informed consent.

Patients are subjected to routine blood investigations such as fasting lipid profile, HbA1c and 2D Echocardiography.

Then patients with dyslipidaemia and Left Ventricular Diastolic Dysfunction are identified based on the tests.

The collected data will be tabulated and analysed and compared between both the groups. The quantitative data will be summarized in excel sheet and Mean , median, standard deviation will be estimated

In order to know the association between Dyslipidemia and Left Ventricular Diastolic Dysfunction simple (PEARSONS) correlation co efficient will be used.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • •1.Patients age >30 years to 65 years 2.Patients diagnosed with T2DM within 6 months of detection who give informed consent 3.FBS ≥ 126 mg/dL and 2-hr plasma glucose ≥200mg/dL during an OGTT, RBS ≥ 200 mg/dL with symptoms (polyuria, polydipsia, polyphagia, weight loss) and Hba1c > 6.5 % as per American Diabetes Association recommendations.

排除标准

  • •1.Known cases of cardiac diseases- Vascular or Ischemic heart disease, heart failure (congestive cardiac failure), cardiomyopathy, atrial fibrillation on treatment.
  • •2.Known hypertensive patients or patients with BP>130/90 mmHg at the time of diagnosis.
  • •3.Known patients of Chronic kidney disease (eGFR < 60 mL/min/1.73m2) 4.Patients with Chronic pulmonary disease.
  • •5.Patients with Thyroid dysfunction.
  • •6.Patients with Severe Anemia and other Hemoglobinopathies.
  • •7.Known cases of malignancies, on treatment.
  • •8.Pregnant women.

结局指标

主要结局

To study the prevalence of left ventricular diastolic dysfunction in asymptomatic newly detected type 2 Diabetes mellitus.

时间窗: At the time of recruitement

To study the correlation of left ventricular diastolic dysfunction with dyslipidemia in asymptomatic newly detected type 2 Diabetes mellitus.

时间窗: At the time of recruitement

次要结局

  • To study the correlation of left ventricular diastolic dysfunction with Glycosylated Hemoglobin levels in asymptomatic newly detected type 2 Diabetes mellitus.(At the time of recruitement)

研究者

发起方
Dr Gundeti Nikhil
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gundeti Nikhil

Kasturba Medical College

研究点 (1)

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