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Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04653805
Enrollment
300000
Registered
2020-12-04
Start date
2017-01-31
Completion date
2022-05-31
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Gender, Type 2 Diabetes

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.

Interventions

OTHERCurrent clinical practice in primary care of patients with type 2 diabetes mellitus

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
31 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Age2007-2013Age registered on the date of data extraction (DTALL-30Jun)
Gender2007-2013Gender registered on the date of data extraction (DTALL-30Jun)
Date of DM diagnosis2007-2013DM onset date registered on the date of data extraction (DTALL-30Jun)
Diagnosis of the most common cardiovascular risk factors2007-2013High Blood Pressure (\>140/90mm Hg), Dyslipidaemia, Smoking and Obesity
Level of of glycated haemoglobin (HbA1c)2007-2013The 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 pressure2007-2013A 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.
Levels of Total Cholesterol (TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C) and triglycerides (TGC)2007-2013A window of up to a year before the DTALL date will be accepted
Body Mass Index (BMI)2007-2013A 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: glomerular filtration estimated by MDRD2007-2013The value closer and prior to data extraction (DTALL-30Jun) will be considered and a window of up to a year before the DTALL accepted
Kidney function: urinary albumin excretion (albumin/creatinine ratio)2007-2013The 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-30Jun2007-2013Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut).
Use of antihypertensive, hypolipidemic, antiplatelet and anticoagulant agents on the DTALL-30Jun2007-2013Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut)
Cardiovascular disease registered on the DTALL-30Jun2007-2013Coronary artery disease, cerebrovascular disease and peripheral artery disease with codes
Causes of mortality in the population with type 2 diabetes during the study period2007-2013Causes of mortality in the population with type 2 diabetes during the study period
Diagnosis of Diabetic retinopathy2007-2013Diagnosis of Diabetic retinopathy
Number of visits with the primary care team in the previous 12 months2007-2013A window of up to a year before the DTALL-30Jun will be considered

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026