Glycaemia and Cardiac Function in Patients With COVID-19 (GLYCOVID-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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1; COVID
• Intervention / Treatment: Other: Glycaemic levels

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Denmark
  • Please Select
    • Hellerup, Please Select, Denmark, 2900
      • Herlev and Gentofte Hospital
    • Hvidovre, Please Select, Denmark, 2650
      • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The intensive care unit cohort; Patients (with or without diabetes) with COVID-19 admitted to the intensive care unit	Other: Glycaemic levels; Glycaemic levels during admission for COVID-19
The hospitalisation cohort; Patients with diabetes and COVID-19 admitted to the medical ward	Other: Glycaemic levels; Glycaemic levels during admission for COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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	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	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	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)	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)	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)	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)	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	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	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)	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)	From first until last assessment during ICU stay (max. 24 hours)

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: H-20024279

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No