Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04879251
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with diabetes who have a worse glycated hemoglobin value (Change from baseline after 1 and 2 year of COVID 19 pandemic)', 'timeFrame': 'Baseline values - before the start of COVID 19 pandemic (1.9.2019 - 1.3.2020)- change from baseline after 1 year 1.4. - 31.7. 2020 and after 2 years (1.4.2021-31.7.2022)', 'description': 'The investigators compare the value of glycated hemoglobin before the start of the COVID 19 pandemic and change from baseline after one year of the pandemic in each participant with diabetes.'}, {'measure': 'Number of patients with diabetes who have a worse LDL cholesterol value (Change from baseline after 1 and 2 year of COVID 19 pandemic)', 'timeFrame': 'Baseline values - before the start of COVID 19 pandemic (1.9.2019 - 1.3.2020)- change from baseline after 1 year 1.4. - 31.7. 2020 and after 2 years (1.4.2021-31.7.2022)', 'description': 'The investigators compare the value of LDL cholesterol before the start of the COVID 19 pandemic and change from baseline after one year of the pandemic in each participant with diabetes.'}, {'measure': 'Number of patients with diabetes who have a higher BMI value (Change from baseline after 1 and 2 year of COVID 19 pandemic)', 'timeFrame': 'Baseline values - before the start of COVID 19 pandemic (1.9.2019 - 1.3.2020)- change from baseline after 1 year 1.4. - 31.7. 2020 and after 2 years (1.4.2021-31.7.2022)', 'description': 'The investigators compare the value of BMI before the start of the COVID 19 pandemic and change from baseline after one year of the pandemic in each participant with diabetes.'}, {'measure': 'Number of patients with diabetes who have a higher BP (blood pressure) value (Change from baseline after 1 and 2 year of COVID 19 pandemic)', 'timeFrame': 'Baseline values - before the start of COVID 19 pandemic (1.9.2019 - 1.3.2020)- change from baseline after 1 year 1.4. - 31.7. 2020 and after 2 years (1.4.2021-31.7.2022)', 'description': 'The investigators compare the value of blood pressure before the start of the COVID 19 pandemic and change from baseline after one year of the pandemic in each participant with diabetes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'COVID 19', 'LDL hyperlipoproteinemia'], 'conditions': ['Diabetes Mellitus', 'Covid19']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare cardiovascular risk factors in patients with diabetes before the start of the pandemic of the COVID 19 (time 1 - T1), after 1 year (time 2 - T2) and 2 years (time 3 - T3) duration. In patients with all types of diabetes, the investigators will compare the value of blood pressure, LDL cholesterol, BMI (body mass index) and glycated haemoglobin in T1, T2 and T3 during outpatient control.', 'detailedDescription': 'Diabetes mellitus (DM) is one of the major risk factors of cardiovascular diseases (CVDs), which are the leading cause of death globally. To reduce overall cardiovascular risk in patients with diabetes, it is necessary, in addition to compensation of diabetes, to reduce other risk factors of cardiovascular diseases. The COVIDs 19 (coronavirus disease of 2019) pandemic has in addition to direct influence (fever, pneumonia, olfactory loss, etc.)1,2 also, a lot of indirect effects. These include psychological effects (long term stress, worries, sadness)3,4,5, increased alcohol consumption, changes in eating habits or decreased physical activity due to restrictions to reduce the spread of the virus in population by government.\n\nThe Czech Republic (Central Europe region) is one of the most affected countries in the World by COVID 19 pandemic. By 1st of March 2021, the SARS-COV2 virus infection was proven in the Czech Republic in 1 247 051 thousand people, which is 11.7% of the population (11 627 per 100 000, in the USA 8743/100 000, in the UK 6300/100 000, in the Germany 2879/100 000, France 5379/100 000)6 Due to a long-lasting serious situation, we expect an adverse effect on number of risk factors for CVDs.\n\nThe objective of this study is to compare cardiovascular risk factors in patients with diabetes before the start of the pandemic of the COVID 19 (time 1 - T1), after 1 year (time 2 - T2) and 2 years (time 3 - T3) duration. In patients with all types of diabetes, the investigators will compare the value of blood pressure, LDL cholesterol, BMI (body mass index) and glycated haemoglobin in T1, T2 and T3 during outpatient control.\n\nThe secondary objective is to evaluate behaviour of patients during COVID 19 pandemic. The investigators will use a questionnaire. It will be anonymous for a more accurate assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetes mellitus of any type', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Diabetes mellitus of any type\n* Planned visit to the outpatient diabetic clinic between 1.4. and 31.7.2021 - T2 (creation of the study group) - University hospital Ostrava, Czech Republic\n* Known values of blood pressure, glycated haemoglobin, LDL cholesterol and BMI before the start of the pandemic (1.3.2020), not older than 6 months and no later than 31.3.2020.\n* Signed consent to the use of anonymous data for scientific purposes and publications.\n\nExclusion Criteria:\n\n* failure to meet the criteria for inclusion'}, 'identificationModule': {'nctId': 'NCT04879251', 'acronym': 'ICOVdia', 'briefTitle': 'The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes.', 'orgStudyIdInfo': {'id': '3/IK-FNO/2021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70852', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'overallOfficials': [{'name': 'Jan Vaclavik', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will be discussed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}