Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653805
• Other study ID #: 7Z20/036
• Status: Completed
• Start date: January 2017
• Est. completion date: May 2022

Study information

• Verified date: December 2021
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300000
• Est. completion date: May 2022
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Gender
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Age registered on the date of data extraction (DTALL-30Jun)	2007-2013
Primary	Gender	Gender registered on the date of data extraction (DTALL-30Jun)	2007-2013
Primary	Date of DM diagnosis	DM onset date registered on the date of data extraction (DTALL-30Jun)	2007-2013
Primary	Diagnosis of the most common cardiovascular risk factors	High Blood Pressure (>140/90mm Hg), Dyslipidaemia, Smoking and Obesity	2007-2013
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cardiovascular disease registered on the DTALL-30Jun	Coronary artery disease, cerebrovascular disease and peripheral artery disease with codes	2007-2013
Primary	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
Primary	Diagnosis of Diabetic retinopathy	Diagnosis of Diabetic retinopathy	2007-2013
Primary	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