NCT04879251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

May 6, 2021

Last Update Submit

December 6, 2022

Conditions

Diabetes MellitusCovid19

Keywords

Diabetes MellitusCOVID 19LDL hyperlipoproteinemia

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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)

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetes mellitus of any type

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, 70852, Czechia

Location

MeSH Terms

Conditions

Diabetes MellitusCOVID-19

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jan Vaclavik

    University Hospital Ostrava

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 10, 2021

Study Start

April 26, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

CZ(1)