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CompletedNCT04969159Updated Jul 20, 2021

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

An observational study in Sepsis, sponsored by Jens Rikardt Andersen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Jens Rikardt Andersen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Sepsis

Keywords

  • septicaemia
  • insulin resitance
  • continous blood glucose
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's enrollment of 18 is below the median of 160 across 929 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Jens Rikardt Andersen is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • not able to understand the protocol
  • not able to co-operate
  • diabetes mellitus of any kind
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Interventions

  • Otherno intervention

    standard treatment in the clinical routine

06

What researchers measure

Primary outcomes

  1. continous blood glucose

    flash glucose monitor on the upper arm

    Time frame: 4 weeks

Secondary outcomes

  1. C-peptide

    plasma concentration

    Time frame: 4 weeks

  2. HOMA-IR

    calculated glucose load test

    Time frame: 4 weeks

07

Study locations

1 site
  • Department of endocrinology, Slagelse Hospiatl
    Slagelse, 4200, Denmark
08

References and documents

Individual participant data

Plan to share: No — no plans

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04969159
Lead sponsor
Jens Rikardt Andersen
Responsible party
Jens Rikardt Andersen (Associate Professor, Primary Investigator, University of Copenhagen) — Sponsor-investigator
First posted
Jul 20, 2021
Start date
Sep 1, 2018
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021
Last update
Jul 20, 2021

Study contacts

Jens R Andersen, MD,MPA
study director · University of Copenhagen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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