Type 2 DiabetesNCT04653805
Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender
An observational study of Type 2 Diabetes and Cardiovascular Risk Factor, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 31 to 100 years
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Risk Factor, Gender
- What is being tested?
- Current clinical practice in primary care of patients with type 2 diabetes mellitus
- How many people
- 300,000 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to May 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with a diagnosis of type 1 diabetes (E10), gestational diabetes (O24), secondary diabetes (E12) or any other type of diabetes (E13)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Type 2 Diabetes, Cardiovascular Risk Factor, Gender
- Being tested
- Current clinical practice in primary care of patients with type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current clinical practice in primary care of patients with type 2 diabetes mellitusOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age registered on the date of data extraction (DTALL-30Jun)
Measured: 2007-2013
Gender
Gender registered on the date of data extraction (DTALL-30Jun)
Measured: 2007-2013
Date of DM diagnosis
DM onset date registered on the date of data extraction (DTALL-30Jun)
Measured: 2007-2013
Diagnosis of the most common cardiovascular risk factors
High Blood Pressure (>140/90mm Hg), Dyslipidaemia, Smoking and Obesity
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
Measured: 2007-2013
Cardiovascular disease registered on the DTALL-30Jun
Coronary artery disease, cerebrovascular disease and peripheral artery disease with codes
Measured: 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
Measured: 2007-2013
Diagnosis of Diabetic retinopathy
Diagnosis of Diabetic retinopathy
Measured: 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
Measured: 2007-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study startJan 2017
- Primary completionOct 2020
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didac Mauricio Puente, MD, PhD, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauAnna Ramirez-Morros, RN, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653805
- Sponsor's protocol ID
- 7Z20/036
- Status last verified
- Dec 2021
- First submitted
- 27 Nov 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences of the Cardiovascular Risk Factors Therapeutic Approach in T2DM Population According to Gender
- ClinicalTrials.gov ID
- NCT04653805
- Acronym / sponsor ID
- 7Z20/036
- Conditions
- Type 2 Diabetes, Cardiovascular Risk Factor, Gender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300,000 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 31 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a diagnosis of type 1 diabetes (E10), gestational diabetes (O24), secondary diabetes (E12) or any other type of diabetes (E13)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current clinical practice in primary care of patients with type 2 diabetes mellitus | Other | – |
Primary outcome
Age
Time frame: 2007-2013
Age registered on the date of data extraction (DTALL-30Jun)
Gender
Time frame: 2007-2013
Gender registered on the date of data extraction (DTALL-30Jun)
Date of DM diagnosis
Time frame: 2007-2013
DM onset date registered on the date of data extraction (DTALL-30Jun)
Diagnosis of the most common cardiovascular risk factors
Time frame: 2007-2013
High Blood Pressure (>140/90mm Hg), Dyslipidaemia, Smoking and Obesity
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
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.
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
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
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
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
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).
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)
Cardiovascular disease registered on the DTALL-30Jun
Time frame: 2007-2013
Coronary artery disease, cerebrovascular disease and peripheral artery disease with codes
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
Diagnosis of Diabetic retinopathy
Time frame: 2007-2013
Diagnosis of Diabetic retinopathy
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didac Mauricio Puente, MD, PhD study director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Anna Ramirez-Morros, RN principal investigator
Institut Català de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Cardiovascular Risk Factor, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: 2007-2013). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.