Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender

NCT ID: NCT04653805

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-05-31

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.

Detailed Description

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Conditions

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Type 2 Diabetes Cardiovascular Risk Factor Gender

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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

Intervention Type OTHER

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)
Minimum Eligible Age

31 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didac Mauricio Puente, MD, PhD

Role: STUDY_DIRECTOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Anna Ramirez-Morros, RN

Role: PRINCIPAL_INVESTIGATOR

Institut Català de la Salut

Locations

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IDIAP Jordi Gol

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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7Z20/036

Identifier Type: -

Identifier Source: org_study_id

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