A Retrospective Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus Participants in Southeast Asia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Cardiometabolic profile: Systolic blood pressure at baseline
研究概览
简要总结
The purpose of the study is to investigate the cardiovascular disease (CVD) risk profile among participants newly diagnosed with type 2 diabetes mellitus (T2DM) in Southeast Asia (CRISTAL SEA). It's a retrospective chart-review across five Southeast Asian countries to characterize newly diagnosed T2DM participants and how their CVD risk is distributed, using data from the year before diagnosis and roughly the first year after diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged greater than equal to (≥) 40 and less than (<) 70 years
- •Male or female
- •Newly diagnosed with T2DM and initiated on anti-hyperglycemic treatment between 1 January 2022 and 31 December 2023
排除标准
- •If any exclusion criterion is met, the participant will be excluded from the study.
- •T1DM or gestational diabetes
- •Prescribed with any anti-hyperglycemic medications before first diagnosis of T2DM
- •Pregnant women
- •With pre-existing atherosclerotic CVD including coronary heart disease, stroke, transient ischemic attack, or peripheral artery disease
- •Died within 12 months after first diagnosis of T2DM
- •Lost to follow-up i.e., no visit 12 months (± 3 months) after first diagnosis of T2DM
研究组 & 干预措施
T2DM Cohort
Participants with T2DM identified in south asian countries.
干预措施: No treatment given (Other)
结局指标
主要结局
Cardiometabolic profile: Systolic blood pressure at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Millimetres of mercury (mmHg).
Cardiometabolic profile: Waist circumference at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in centimetre (cm).
Cardiometabolic profile: Hip circumference at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in cm.
Cardiometabolic profile: Height at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in cm.
Cardiometabolic profile: Weight at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in kilogram (kg).
Cardiometabolic profile: Total cholesterol at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in millimoles per liter (mmol/L).
Cardiometabolic profile: High-density lipoprotein cholesterol (HDL-C) at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in mmol/L.
Cardiometabolic profile: Low-density lipoprotein cholesterol (LDL-C) at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in mmol/L.
Cardiometabolic profile: Non High-density lipoprotein cholesterol (Non-HDL-C) at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in mmol/L.
Cardiometabolic profile: Triglycerides at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in mmol/L.
Cardiometabolic profile: Glycated haemoglobin (HbA1c) at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in mmol/L.
Cardiometabolic profile: Fasting plasma glucose (FPG) at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in mmol/L.
Cardiometabolic profile: estimated glomerular filtration rate (eGFR) at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in mL/min/1.73m\^2.
Cardiometabolic profile: Serum creatinine at baseline
时间窗: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Measured in mL/min/1.73m\^2.
Proportion of participants classified into CVD risk categories (very high, high, moderate or low risk) - Yes/No
时间窗: At baseline: Status at the index date or, if unavailable, the closest record within the 12 months prior to the index date
Measured in percentage (%) of participants.
次要结局
未报告次要终点