Diabetes MellitusGLYCOVID-19NCT04410718
Glycaemia and Cardiac Function in Patients With COVID-19
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
Trial summary
The study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- Glycaemic levels
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Apr 2020to 30 Jun 2021
- 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: The present study aims to evaluate the effect of glycaemia on cardiac function in patients with COVID-19 by examining cardiac function by echocardiography in two patient groups: 1) hospitalised COVID-19 patients with diabetes admitted to the medical ward 2) COVID-19 patients with or without diabetes admitted to the ICU.
The ICU cohort - Inclusion criteria
- Informed and written consent
- Age ≥18 years
- Verified COVID-19
- Admission to the ICU within the last 24 hours
- Type 1 or type 2 diabetes prior to admission (the diabetes sub-group only)
The ICU cohort - Exclusion criteria
- Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial fibrillation will be allowed)
- Pacemaker rhythm
- Severe valve disease
The hospitalisation cohort - inclusion criteria
- Informed and written consent
- Age ≥18 years
- Verified COVID-19
- Admission to medical ward within the last 24 hours
- Type 1 or type 2 diabetes prior to admission
The hospitalisation cohort - Exclusion criteria
- Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial fibrillation will be allowed)
- Pacemaker rhythm
- Severe valve disease
Withdrawal criteria
- The participants may withdraw at will at any time
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Herlev and Gentofte Hospital
Hellerup, Please Select, 2900
Hvidovre Hospital
Hvidovre, Please Select, 2650
About this study
The study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort).
The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.
- Being tested
- Glycaemic levels
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycaemic levelsOther
Glycaemic levels during admission for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| The intensive care unit cohort | Patients (with or without diabetes) with COVID-19 admitted to the intensive care unit Receives: Other: Glycaemic levels | |
| The hospitalisation cohort | Patients with diabetes and COVID-19 admitted to the medical ward Receives: Other: Glycaemic levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose levels and left ventricular ejection fraction
The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Secondary outcomes (14)
Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function
Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and strain analysis
The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and mitral annular systolic velocity
The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and left ventricular ejection fraction (sub-group analysis)
Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and strain analysis (sub-group analysis)
Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and mitral annular systolic velocity (sub-group analysis)
Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
HbA1c, Plasma glucose levels and strain analysis
Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
HbA1c, Plasma glucose levels and mitral annular systolic velocity
Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measured: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Diabetes status and whole blood coagulability and fibrinolysis
Difference in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes at time of admission to the ICU (ICU cohort only)
Measured: At time of admission to the ICU (max. 24 hours after admission to the ICU)
Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay
Difference in change in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes treated at the ICU (ICU cohort only)
Measured: From first until last assessment during ICU stay (max. 24 hours).
Prognostic value of TEG analysis
The prognostic value of cardiac function and TEG on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
Measured: From time of admission and until four weeks after admission
Prognostic value of cardiac function
The prognostic value of cardiac function on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
Measured: From time of admission and until four weeks after admission
Diabetes status and high-sensitivity troponins
Difference in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
Measured: At the time of admission to the ICU (max. 24 hours after admission to the ICU)
Diabetes status and change high-sensitivity troponins
Difference in change in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
Measured: From first until last assessment during ICU stay (max. 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start20 Apr 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Andersen, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410718
- Sponsor's protocol ID
- H-20024279
- Acronym
- GLYCOVID-19
- Status last verified
- Nov 2022
- First submitted
- 5 May 2020
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemia and Cardiac Function in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04410718
- Acronym / sponsor ID
- GLYCOVID-19 / H-20024279
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 1 Jun 2020 (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 study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort).
The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intensive care unit cohort | – | Other: Glycaemic levelsPatients (with or without diabetes) with COVID-19 admitted to the intensive care unit |
| The hospitalisation cohort | – | Other: Glycaemic levelsPatients with diabetes and COVID-19 admitted to the medical ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The present study aims to evaluate the effect of glycaemia on cardiac function in patients with COVID-19 by examining cardiac function by echocardiography in two patient groups: 1) hospitalised COVID-19 patients with diabetes admitted to the medical ward 2) COVID-19 patients with or without diabetes admitted to the ICU.
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 |
|---|---|---|
| Glycaemic levelsGlycaemic levels during admission for COVID-19 | Other | The hospitalisation cohort, The intensive care unit cohort |
Primary outcome
Plasma glucose levels and left ventricular ejection fraction
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)
14 secondary outcomes
Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and strain analysis
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and mitral annular systolic velocity
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and left ventricular ejection fraction (sub-group analysis)
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and strain analysis (sub-group analysis)
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Plasma glucose levels and mitral annular systolic velocity (sub-group analysis)
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
HbA1c, Plasma glucose levels and strain analysis
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
HbA1c, Plasma glucose levels and mitral annular systolic velocity
Time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Diabetes status and whole blood coagulability and fibrinolysis
Time frame: At time of admission to the ICU (max. 24 hours after admission to the ICU)
Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay
Time frame: From first until last assessment during ICU stay (max. 24 hours).
Prognostic value of TEG analysis
Time frame: From time of admission and until four weeks after admission
Prognostic value of cardiac function
Time frame: From time of admission and until four weeks after admission
Diabetes status and high-sensitivity troponins
Time frame: At the time of admission to the ICU (max. 24 hours after admission to the ICU)
Diabetes status and change high-sensitivity troponins
Time frame: From first until last assessment during ICU stay (max. 24 hours)
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 29 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Diabetes Mellitus, Type 2, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Plasma glucose levels and left ventricular ejection fraction (time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).). 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 29 Nov 2022.