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NCT Number: NCT04653805

Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender

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.

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Key information

Conditions

Type 2 Diabetes Behavior Cardiovascular Risk Factor Coitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Gender Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Sexual Behavior

Age range

31 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IDIAP Jordi Gol

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

Primary outcomes

  1. Age

    Time frame: 2007-2013

    Age registered on the date of data extraction (DTALL-30Jun)

  2. Gender

    Time frame: 2007-2013

    Gender registered on the date of data extraction (DTALL-30Jun)

  3. Date of DM diagnosis

    Time frame: 2007-2013

    DM onset date registered on the date of data extraction (DTALL-30Jun)

  4. Diagnosis of the most common cardiovascular risk factors

    Time frame: 2007-2013

    High Blood Pressure (>140/90mm Hg), Dyslipidaemia, Smoking and Obesity

  5. Level of of glycated haemoglobin (HbA1c)

    Time frame: 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

  6. Average of the three last measurements of systolic and diastolic blood pressure

    Time frame: 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.

  7. Levels of Total Cholesterol (TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C) and triglycerides (TGC)

    Time frame: 2007-2013

    A window of up to a year before the DTALL date will be accepted

  8. Body Mass Index (BMI)

    Time frame: 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

  9. Kidney function: glomerular filtration estimated by MDRD

    Time frame: 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

  10. Kidney function: urinary albumin excretion (albumin/creatinine ratio)

    Time frame: 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

  11. Use of hypoglycaemic agents and insulin on the DTALL-30Jun

    Time frame: 2007-2013

    Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut).

  12. Use of antihypertensive, hypolipidemic, antiplatelet and anticoagulant agents on the DTALL-30Jun

    Time frame: 2007-2013

    Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut)

  13. Cardiovascular disease registered on the DTALL-30Jun

    Time frame: 2007-2013

    Coronary artery disease, cerebrovascular disease and peripheral artery disease with codes

  14. Causes of mortality in the population with type 2 diabetes during the study period

    Time frame: 2007-2013

    Causes of mortality in the population with type 2 diabetes during the study period

  15. Diagnosis of Diabetic retinopathy

    Time frame: 2007-2013

    Diagnosis of Diabetic retinopathy

  16. Number of visits with the primary care team in the previous 12 months

    Time frame: 2007-2013

    A window of up to a year before the DTALL-30Jun will be considered

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Dec 4, 2020
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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