Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender

Study Overview
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Brief Summary
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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.

Official Title
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Differences of the Cardiovascular Risk Factors Therapeutic Approach in T2DM Population According to Gender

Conditions
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Type 2 Diabetes, Cardiovascular Risk Factor, Gender

Intervention / Treatment
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* Other: Current clinical practice in primary care of patients with type 2 diabetes mellitus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: - Patients with a diagnosis of type 1 diabetes (E10), gestational diabetes (O24), secondary diabetes (E12) or any other type of diabetes (E13)

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Current clinical practice in primary care of patients with type 2 diabetes mellitus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age registered on the date of data extraction (DTALL-30Jun) | 2007-2013 | 
| Gender | Gender registered on the date of data extraction (DTALL-30Jun) | 2007-2013 | 
| Date of DM diagnosis | DM onset date registered on the date of data extraction (DTALL-30Jun) | 2007-2013 | 
| Diagnosis of the most common cardiovascular risk factors | High Blood Pressure (>140/90mm Hg), Dyslipidaemia, Smoking and Obesity | 2007-2013 | 
| Level of of glycated haemoglobin (HbA1c) | 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 | 2007-2013 | 
| Average of the three last measurements of systolic and diastolic blood pressure | 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. | 2007-2013 | 
| Levels of Total Cholesterol (TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C) and triglycerides (TGC) | A window of up to a year before the DTALL date will be accepted | 2007-2013 | 
| Body Mass Index (BMI) | A window of up to a year before the DTALL-30Jun will be accepted. Height will be measured in m and weight in kg | 2007-2013 | 
| Kidney function: glomerular filtration estimated by MDRD | 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 | 2007-2013 | 
| Kidney function: urinary albumin excretion (albumin/creatinine ratio) | 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 | 2007-2013 | 
| Use of hypoglycaemic agents and insulin on the DTALL-30Jun | Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut). | 2007-2013 | 
| Use of antihypertensive, hypolipidemic, antiplatelet and anticoagulant agents on the DTALL-30Jun | Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut) | 2007-2013 | 
| Cardiovascular disease registered on the DTALL-30Jun | Coronary artery disease, cerebrovascular disease and peripheral artery disease with codes | 2007-2013 | 
| Causes of mortality in the population with type 2 diabetes during the study period | Causes of mortality in the population with type 2 diabetes during the study period | 2007-2013 | 
| Diagnosis of Diabetic retinopathy | Diagnosis of Diabetic retinopathy | 2007-2013 | 
| Number of visits with the primary care team in the previous 12 months | A window of up to a year before the DTALL-30Jun will be considered | 2007-2013 |