Medanta Cardiometabolic Disease Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Novel biomarkers profiling of type 2 diabetes and coronary artery disease
研究概览
简要总结
Cardiovascular disease and diabetes are reaching epidemic proportions in the United States and in developing countries. India, in particular, has shown marked increases in the rates of these two diseases with major public health impact. The epidemiology and mechanism underlying these trends are incompletely understood. It is known that CAD risk has a strong genetic component . Research work at Duke University, NC, USA in Caucasian population has already suggested that novel mechanisms of diabetes and cardiovascular disease risk and have also identified novel diagnostic and prognostic biomarkers. Through this proposal, we will expand Duke’s previous work in the clinical and molecular epidemiology of type II diabetes and cardiovascular disease (CVD) in Indian populations. This work will help us to better define the epidemiology of diabetes and CVD in Indian populations and advance our understanding of molecular mechanisms related to the dramatic increase in diabetes and CVD risk in transitioning Indian populations, xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary goals of this component of the study proposal are :
1) To identify novel biomarkers of type II diabetes and coronary artery disease in an Indian population referred for cardiac catheterization at Medanta Hospital. Metabolomic profiling and gene expression assays on 400 participants referred for cardiac catheterization in 2x2 factorial design of type II diabetes and coronary artery disease (+DM/+CAD vs. +DM/-CAD vs. –DM/+CAD vs. –DM/-CAD).
2) To conduct a small-scale pilot “proof-of-principle†effort of clinical and electrocardiographic data and biological sample collection in rural Delhi. Clinical, biochemical and ECG evaluation of 300 participants in Medanta cardiovascular disease outreach camp.
In this study, we will analyse the blood samples from the study population for genetic and metabolomic profiling.
Our research will help to identify patients of Indian origin who are at high risk for developing disease and will add to the epidemiologic and biomarker data of CVD in urban and rural India. This study therefore has great implications for disease prevention and for public health improvement in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •I.Are 18-80 years old, II.Have the ability to give informed consent and III.Are a patient at the Medanta-The Medicity Hospital outpatient clinic, cardiac catheterization laboratory or at the rural camps organized by the Medanta-The Medicity Hospital you are eligible to participate in the study.
- •IV.Are undergoing a cardiac catheterization, it should be because there is a concern for coronary artery disease and the cardiac catheterization should not be an emergency procedure.
排除标准
- •I.Are being unable to give informed consent, II.Are undergoing an emergency cardiac catheterization, III.Are having severe anemia, IV.Are having a planned surgery within 24 hours of cardiac catheterization.
结局指标
主要结局
Novel biomarkers profiling of type 2 diabetes and coronary artery disease
时间窗: Novel biomarkers profiling of type 2 diabetes and coronary artery disease
次要结局
- Identification of patients of Indian origin who are at greater risk of developing type 2 diabetes and coronary artery disease(Identification of patients of Indian origin who are at greater risk of developing type 2 diabetes and coronary artery disease)