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Clinical Trials/NCT04969159
NCT04969159CompletedNot Applicable

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

Jens Rikardt Andersen1 site in 1 country18 target enrollmentStarted: September 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
18
Locations
1
Primary Endpoint
continous blood glucose

Study Overview

Brief Summary

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

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

continous blood glucose

Time Frame: 4 weeks

flash glucose monitor on the upper arm

Secondary Outcomes

  • C-peptide(4 weeks)
  • HOMA-IR(4 weeks)

Investigators

Sponsor
Jens Rikardt Andersen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jens Rikardt Andersen

Associate Professor, Primary Investigator

University of Copenhagen

Study Sites (1)

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