Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Cardiovascular Risk Factor; Gender
• Intervention / Treatment: Other: Current clinical practice in primary care of patients with type 2 diabetes mellitus

• Study Type: Observational
• Enrollment (Actual): 300000

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • IDIAP Jordi Gol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Study Director: Didac Mauricio Puente, MD, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Principal Investigator: Anna Ramirez-Morros, RN, Institut Català de la Salut

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 7Z20/036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No