Glycaemia and Cardiac Function in Patients With COVID-19

NCT04410718 | Completed

• 1 other identifier: H-20024279
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; COVID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function

  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 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 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)

  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)

  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).

Study Arms (2)

The intensive care unit cohort

Patients (with or without diabetes) with COVID-19 admitted to the intensive care unit

Other: Glycaemic levels

The hospitalisation cohort

Patients with diabetes and COVID-19 admitted to the medical ward

Other: Glycaemic levels

Interventions

Glycaemic levels OTHER

Glycaemic levels during admission for COVID-19

The hospitalisation cohort; The intensive care unit cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Pacemaker rhythm
• Severe valve disease
• 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
• Pacemaker rhythm
• Severe valve disease
• Withdrawal criteria
• \- The participants may withdraw at will at any time

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (2)

Herlev and Gentofte Hospital

Hellerup, Please Select, 2900, Denmark

Location

Hvidovre Hospital

Hvidovre, Please Select, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: June 1, 2020
• Study Start: April 20, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

DK (2)