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Completed

NCT Number: NCT04410718

Glycaemia and Cardiac Function in Patients With COVID-19

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.

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases COVID Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev and Gentofte Hospital, Hellerup, Please Select, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glycaemic levels

Other

Glycaemic levels during admission for COVID-19

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

    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)

  2. 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).

    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)

  3. 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).

    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)

  4. 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).

    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

  5. 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).

    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

  6. 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).

    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

  7. 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).

    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)

  8. 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).

    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)

  9. 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)

    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)

  10. 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).

    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)

  11. Prognostic value of TEG analysis

    Time frame: From time of admission and until four weeks after admission

    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

  12. Prognostic value of cardiac function

    Time frame: From time of admission and until four weeks after admission

    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

  13. Diabetes status and high-sensitivity troponins

    Time frame: At the time of admission to the ICU (max. 24 hours after admission to the ICU)

    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)

  14. Diabetes status and change high-sensitivity troponins

    Time frame: From first until last assessment during ICU stay (max. 24 hours)

    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)

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Acronym: GLYCOVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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