Diabetes MellitusICOVdiaNCT04879251
The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes
An observational study of Diabetes Mellitus and Covid19, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Covid19
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 26 Apr 2021to 31 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetes mellitus of any type
Who may be able to join
- 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.
Who cannot join
- failure to meet the criteria for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes.
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Covid19
- Being tested
- No intervention
- Keywords
- Diabetes Mellitus, COVID 19, LDL hyperlipoproteinemia
- Medical subject headings
- Diabetes Mellitus, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with diabetes who have a worse glycated hemoglobin value (Change from baseline after 1 and 2 year of COVID 19 pandemic)
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.
Measured: 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)
Number of patients with diabetes who have a worse LDL cholesterol value (Change from baseline after 1 and 2 year of COVID 19 pandemic)
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.
Measured: 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)
Number of patients with diabetes who have a higher BMI value (Change from baseline after 1 and 2 year of COVID 19 pandemic)
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.
Measured: 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)
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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start26 Apr 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vaclavik, Study chair, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879251
- Sponsor's protocol ID
- 3/IK-FNO/2021
- Acronym
- ICOVdia
- Status last verified
- Dec 2022
- First submitted
- 6 May 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be discussed.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes.
- ClinicalTrials.gov ID
- NCT04879251
- Acronym / sponsor ID
- ICOVdia / 3/IK-FNO/2021
- Conditions
- Diabetes Mellitus, Covid19
- Keywords
- Diabetes Mellitus, COVID 19, LDL hyperlipoproteinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 10 May 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetes mellitus of any type
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- failure to meet the criteria for inclusion
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Number of patients with diabetes who have a worse glycated hemoglobin value (Change from baseline after 1 and 2 year of COVID 19 pandemic)
Time frame: 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)
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.
Number of patients with diabetes who have a worse LDL cholesterol value (Change from baseline after 1 and 2 year of COVID 19 pandemic)
Time frame: 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)
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.
Number of patients with diabetes who have a higher BMI value (Change from baseline after 1 and 2 year of COVID 19 pandemic)
Time frame: 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)
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.
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)
Time frame: 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)
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.
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 7 Dec 2022.
- Individual participant dataSharing planned: Undecided. Will be discussed.
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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.
Jan Vaclavik study chair
University Hospital Ostrava
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 Diabetes Mellitus and Covid19, run by University Hospital Ostrava at 1 site in Czechia.
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 5 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 7 Dec 2022. 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 Czechia. 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?
Number of patients with diabetes who have a worse glycated hemoglobin value (Change from baseline after 1 and 2 year of COVID 19 pandemic) (time frame: 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)). The study lists 4 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 7 Dec 2022.