Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04653805
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2020-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2020-11-27', 'studyFirstSubmitQcDate': '2020-11-27', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age', 'timeFrame': '2007-2013', 'description': 'Age registered on the date of data extraction (DTALL-30Jun)'}, {'measure': 'Gender', 'timeFrame': '2007-2013', 'description': 'Gender registered on the date of data extraction (DTALL-30Jun)'}, {'measure': 'Date of DM diagnosis', 'timeFrame': '2007-2013', 'description': 'DM onset date registered on the date of data extraction (DTALL-30Jun)'}, {'measure': 'Diagnosis of the most common cardiovascular risk factors', 'timeFrame': '2007-2013', 'description': 'High Blood Pressure (\\>140/90mm Hg), Dyslipidaemia, Smoking and Obesity'}, {'measure': 'Level of of glycated haemoglobin (HbA1c)', 'timeFrame': '2007-2013', 'description': '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'}, {'measure': 'Average of the three last measurements of systolic and diastolic blood pressure', 'timeFrame': '2007-2013', 'description': '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.'}, {'measure': 'Levels of Total Cholesterol (TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C) and triglycerides (TGC)', 'timeFrame': '2007-2013', 'description': 'A window of up to a year before the DTALL date will be accepted'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '2007-2013', 'description': 'A window of up to a year before the DTALL-30Jun will be accepted. Height will be measured in m and weight in kg'}, {'measure': 'Kidney function: glomerular filtration estimated by MDRD', 'timeFrame': '2007-2013', 'description': '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'}, {'measure': 'Kidney function: urinary albumin excretion (albumin/creatinine ratio)', 'timeFrame': '2007-2013', 'description': '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'}, {'measure': 'Use of hypoglycaemic agents and insulin on the DTALL-30Jun', 'timeFrame': '2007-2013', 'description': 'Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut).'}, {'measure': 'Use of antihypertensive, hypolipidemic, antiplatelet and anticoagulant agents on the DTALL-30Jun', 'timeFrame': '2007-2013', 'description': 'Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut)'}, {'measure': 'Cardiovascular disease registered on the DTALL-30Jun', 'timeFrame': '2007-2013', 'description': 'Coronary artery disease, cerebrovascular disease and peripheral artery disease with codes'}, {'measure': 'Causes of mortality in the population with type 2 diabetes during the study period', 'timeFrame': '2007-2013', 'description': 'Causes of mortality in the population with type 2 diabetes during the study period'}, {'measure': 'Diagnosis of Diabetic retinopathy', 'timeFrame': '2007-2013', 'description': 'Diagnosis of Diabetic retinopathy'}, {'measure': 'Number of visits with the primary care team in the previous 12 months', 'timeFrame': '2007-2013', 'description': 'A window of up to a year before the DTALL-30Jun will be considered'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Cardiovascular Risk Factor', 'Gender']}, 'descriptionModule': {'briefSummary': '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.\n\nHypothesis: The cardiovascular risk factors management in women with T2DM is different than in men with T2DM.\n\nAims: To assess the therapeutic approach of cardiovascular risk factors and the occurrence of cardiovascular events among women in comparison to men with T2DM.\n\nMethodology: Observational study based on clinical records of primary health care from T2DM patients in Catalonia (2007-2013).\n\nSource: 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.\n\nApplicability and Relevance: This study is intended to serve to identify the points of improvement of the cardiovascular risk factors therapeutic approach in women.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '31 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients \\> 30 years of age with a clinical record in the SIDIAP database.\n* 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\n\nExclusion Criteria:\n\n\\- Patients with a diagnosis of type 1 diabetes (E10), gestational diabetes (O24), secondary diabetes (E12) or any other type of diabetes (E13)'}, 'identificationModule': {'nctId': 'NCT04653805', 'briefTitle': 'Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Differences of the Cardiovascular Risk Factors Therapeutic Approach in T2DM Population According to Gender', 'orgStudyIdInfo': {'id': '7Z20/036'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Current clinical practice in primary care of patients with type 2 diabetes mellitus', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'IDIAP Jordi Gol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Didac Mauricio Puente, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, {'name': 'Anna Ramirez-Morros, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Català de la Salut'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}