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

Completed

• Conditions: Sepsis

• Registration Number: NCT04969159
• Lead Sponsor: Jens Rikardt Andersen

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 Timeline

• Study Start: 2018-09-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-09
• Last Update Submitted: 2021-07-09
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
continous blood glucose	4 weeks	flash glucose monitor on the upper arm

Secondary Outcome Measures

Name	Time	Method
C-peptide	4 weeks	plasma concentration
HOMA-IR	4 weeks	calculated glucose load test

Trial Locations

Locations (1)

Department of endocrinology, Slagelse Hospiatl; 🇩🇰 Slagelse, Denmark