A Cross-Sectional Study to Assess the Prevalence of Cardiovascular Disease (CVD) in Individuals with Type 2 Diabetes Mellitus (T2DM) in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 6,500
- 试验地点
- 18
- 主要终点
- Proportion of individuals with established CVD i.e. who have been diagnosed with either cerebrovascular disease, coronary heart disease (CHD), heart failure, cardiac arrhythmia or conduction abnormalities, aortic disease, peripheral artery disease (PAD), or carotid artery disease
研究概览
简要总结
This is a multi-center, non-interventional, cross-sectional study assessing the prevalence of CVD and describing cardio-renal risk factors among individuals with T2DM in India. By estimating the prevalence of CVD and exploring associated cardio-renal risk factors, the study seeks to provide valuable insights that will help contextualize the disease burden and unmet needs. Additionally, the study strives to provide the most recent evidence on CVD prevalence in Indian individuals with T2DM, focusing on baseline demographic and clinical characterization.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The following criteria are necessary for subjects to be eligible for this study: 1.Male of female individuals with T2DM, greater than or equal to 18 years of age
- •A confirmed diagnosis of T2DM, and the availability of data before ethical clearance at every participating institution
- •Medical records available between 01 January 2024 to 30 September 2024 ought to have the data points required for the primary and secondary objectives.
- •Medical records must have at least 6 months (greater than or equal to 180 days) of follow-up data from the date of diagnosis.
排除标准
- •Subjects who meet any of the following criteria will be disqualified from entering the study: 1.Diagnosis of Type 1 diabetes, or maturity-onset diabetes of the young (MODY) 2.Known congenital heart disease or malformation.
结局指标
主要结局
Proportion of individuals with established CVD i.e. who have been diagnosed with either cerebrovascular disease, coronary heart disease (CHD), heart failure, cardiac arrhythmia or conduction abnormalities, aortic disease, peripheral artery disease (PAD), or carotid artery disease
时间窗: At least 180 days (6 months) from the date of diagnosis
次要结局
- · Proportion of individuals with renal disease & cardio-renal risk factors.(· Characterize individuals based on demographics, clinical parameters & treatment patterns)
研究者
Dr Arjun Nair
Novo Nordisk India Private Limited