Clinical trial NCT04653805: Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender
Official title: Differences of the Cardiovascular Risk Factors Therapeutic Approach in T2DM Population According to Gender
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Cardiovascular Risk Factor
Gender
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 300000
Sex: ALL
Minimum age (years): 31
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is selected from 5,8 million people from the 282 primary care centres of the Catalan Health Service identified with an anonymized personal identifier and included in a unique patient registry called "SIDIAP" for primary care in Catalonia

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Age
timeFrame: 2007-2013
measure: Gender
timeFrame: 2007-2013
measure: Date of DM diagnosis
timeFrame: 2007-2013
measure: Diagnosis of the most common cardiovascular risk factors
timeFrame: 2007-2013
measure: Level of of glycated haemoglobin (HbA1c)
timeFrame: 2007-2013
measure: Average of the three last measurements of systolic and diastolic blood pressure
timeFrame: 2007-2013
measure: Levels of Total Cholesterol (TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C) and triglycerides (TGC)
timeFrame: 2007-2013
measure: Body Mass Index (BMI)
timeFrame: 2007-2013
measure: Kidney function: glomerular filtration estimated by MDRD
timeFrame: 2007-2013
measure: Kidney function: urinary albumin excretion (albumin/creatinine ratio)
timeFrame: 2007-2013
measure: Use of hypoglycaemic agents and insulin on the DTALL-30Jun
timeFrame: 2007-2013
measure: Use of antihypertensive, hypolipidemic, antiplatelet and anticoagulant agents on the DTALL-30Jun
timeFrame: 2007-2013
measure: Cardiovascular disease registered on the DTALL-30Jun
timeFrame: 2007-2013
measure: Causes of mortality in the population with type 2 diabetes during the study period
timeFrame: 2007-2013
measure: Diagnosis of Diabetic retinopathy
timeFrame: 2007-2013
measure: Number of visits with the primary care team in the previous 12 months
timeFrame: 2007-2013
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Didac Mauricio Puente, MD, PhD
role: STUDY_DIRECTOR
affiliation: Institut Català de la Salut
name: Anna Ramirez-Morros, RN
role: PRINCIPAL_INVESTIGATOR
References: