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Completed

NCT Number: NCT04969159

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of endocrinology, Slagelse Hospiatl

Slagelse, 4200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

standard treatment in the clinical routine

Primary outcomes

  1. continous blood glucose

    Time frame: 4 weeks

    flash glucose monitor on the upper arm

Secondary outcomes

  1. C-peptide

    Time frame: 4 weeks

    plasma concentration

  2. HOMA-IR

    Time frame: 4 weeks

    calculated glucose load test

Sponsors and collaborators

Lead sponsor

Jens Rikardt Andersen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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