Differences of the Cardiovascular Risk Factors Therapeutic Approach in T2DM Population According to Gender
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300,000
- 试验地点
- 1
- 主要终点
- Use of antihypertensive, hypolipidemic, antiplatelet and anticoagulant agents on the DTALL-30Jun
研究概览
简要总结
Background: Patients with type 2 diabetes mellitus (T2DM) are at 2- to 4-fold higher risk of cardiovascular mortality compared with non-diabetic subjects. Cardiovascular disease (CVD) is the main cause of death in almost half of diabetic population in Spain. Female patients with T2DM have up to 40% excess risk of CVD compared with men and the causes are still unknown. It is argued that a tight control of cardiovascular risk factors could improve the situation.
Hypothesis: The cardiovascular risk factors management in women with T2DM is different than in men with T2DM.
Aims: To assess the therapeutic approach of cardiovascular risk factors and the occurrence of cardiovascular events among women in comparison to men with T2DM.
Methodology: Observational study based on clinical records of primary health care from T2DM patients in Catalonia (2007-2013).
Source: SIDIAP database. Analysis: The two study groups (women and men) will be matched to ensure balance in terms of basal comorbidities and previous cardiovascular disease in order to describe the study group characteristics and to perform a multivariate modeling approach.
Applicability and Relevance: This study is intended to serve to identify the points of improvement of the cardiovascular risk factors therapeutic approach in women.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 31 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients > 30 years of age with a clinical record in the SIDIAP database.
- •Patients with a diagnosis of type 2 diabetes (codes ICD10: E11, E11.0-E11.9, E14, E14.0-E14.9) on DTALL-30Jun of each year
排除标准
- •Patients with a diagnosis of type 1 diabetes (E10), gestational diabetes (O24), secondary diabetes (E12) or any other type of diabetes (E13)
结局指标
主要结局
Use of antihypertensive, hypolipidemic, antiplatelet and anticoagulant agents on the DTALL-30Jun
时间窗: 2007-2013
Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut)
Number of visits with the primary care team in the previous 12 months
时间窗: 2007-2013
A window of up to a year before the DTALL-30Jun will be considered
Diagnosis of the most common cardiovascular risk factors
时间窗: 2007-2013
High Blood Pressure (\>140/90mm Hg), Dyslipidaemia, Smoking and Obesity
Diagnosis of Diabetic retinopathy
时间窗: 2007-2013
Diagnosis of Diabetic retinopathy
Date of DM diagnosis
时间窗: 2007-2013
DM onset date registered on the date of data extraction (DTALL-30Jun)
Level of of glycated haemoglobin (HbA1c)
时间窗: 2007-2013
The value closer and prior to data extraction (DTALL-30Jun) will be considered and a window of up to a year before the DTALL accepted
Body Mass Index (BMI)
时间窗: 2007-2013
A window of up to a year before the DTALL-30Jun will be accepted. Height will be measured in m and weight in kg
Kidney function: urinary albumin excretion (albumin/creatinine ratio)
时间窗: 2007-2013
The value closer and prior to data extraction (DTALL-30Jun) will be considered and a window of up to a year before the DTALL accepted
Average of the three last measurements of systolic and diastolic blood pressure
时间窗: 2007-2013
A window of up to a year before the DTALL date will be accepted. If there are no 3BP measurements, the ones available closer to DTALL will be accepted.
Cardiovascular disease registered on the DTALL-30Jun
时间窗: 2007-2013
Coronary artery disease, cerebrovascular disease and peripheral artery disease with codes
Causes of mortality in the population with type 2 diabetes during the study period
时间窗: 2007-2013
Causes of mortality in the population with type 2 diabetes during the study period
Age
时间窗: 2007-2013
Age registered on the date of data extraction (DTALL-30Jun)
Gender
时间窗: 2007-2013
Gender registered on the date of data extraction (DTALL-30Jun)
Levels of Total Cholesterol (TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C) and triglycerides (TGC)
时间窗: 2007-2013
A window of up to a year before the DTALL date will be accepted
Kidney function: glomerular filtration estimated by MDRD
时间窗: 2007-2013
The value closer and prior to data extraction (DTALL-30Jun) will be considered and a window of up to a year before the DTALL accepted
Use of hypoglycaemic agents and insulin on the DTALL-30Jun
时间窗: 2007-2013
Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut).
次要结局
未报告次要终点