Clinical trial NCT04879251: The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes
Official title: The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Covid19
Keywords: Diabetes Mellitus
COVID 19
LDL hyperlipoproteinemia
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetes mellitus of any type

Brief summary: 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.

Detailed description: 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.

The 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.

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.

The 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Diabetes mellitus of any type
* 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
* 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.
* Signed consent to the use of anonymous data for scientific purposes and publications.

Exclusion Criteria:

* failure to meet the criteria for inclusion

Primary outcomes:
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)
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)
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)
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)
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
Study officials:
affiliation: University Hospital Ostrava
name: Jan Vaclavik
role: STUDY_CHAIR
References: