The Degree, Duration and Frequency of Insulin Resistance in Non-operated Patients With Sepsis

Insulin Resistance in Septic Patients in the Acute Phase and After Discharge From Hospital

Surgery induces insulin resistance lasting for 2-3 weeks. We wanted to elucidate if stress-metabolic, medical conditions carry the same effect.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: no intervention

Detailed Description

Background: Insulin resistance is well documented after surgery in a severity positively correlated to the degree of trauma (Thorell et al. 1999; Chambrier et al. 2000). Similar phenomena have been described in severely ill patients in ICU with consequences for the survival (Van den Berghe et al. 2001; The NICE-SUGAR Study Investigators 2009). The documentation, however, is scarce and the extent is unknown in acutely ill patients with sepsis.

Method: Adult, consecutive, non-diabetic patients with elevated CRP, leukocyte counts, SOFA-score of ≥ 2 were monitored with fasting p-C-peptide, blood glucose, CRP, leukocyte count and HOMA-IR at admittance, discharge and at two follow-up visits 2 weeks and 4 weeks after admission. Blood glucose levels were measured continuously during the whole study period with a flash glucose monitor mounted on the patients' upper arm. The diagnosis was sepsis, urosepsis, pneumonia, erysipecosis, bacteremia, infection with unknow focus and covid-19.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Denmark
  • Slagelse, Denmark, 4200
    • Department of endocrinology, Slagelse Hospiatl

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

Consecutive adults acutely admnitted to hospital with diagnosed sepsis on bacterial basis or on basis of covid-19

Description

Inclusion Criteria:

• elevated CRP on acute asdmission
• elevated leukocyte count on admission
• SOFA-score ≥ 2
• diagnosis: bacterial sepsis
• full age and authority

Exclusion Criteria:

• not able to understand the protocol
• not able to co-operate
• diabetes mellitus of any kind

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
continous blood glucose	flash glucose monitor on the upper arm	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-peptide	plasma concentration	4 weeks
HOMA-IR	calculated glucose load test	4 weeks

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Investigators: Study Director: Jens R Andersen, MD,MPA, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: septicaemia; insulin resitance; continous blood glucose
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hyperinsulinism; Sepsis; Insulin Resistance
• Other Study ID Numbers: insulin - sepsis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plans

Drug and device information, study documents

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