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NCT04969159 Clinical Trial

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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04969159
Other study ID # insulin - sepsis
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date March 1, 2021

Study information
Verified date July 2021
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
standard treatment in the clinical routine

Locations
Country Name City State
Denmark Department of endocrinology, Slagelse Hospiatl Slagelse

Sponsors (1)
Lead Sponsor Collaborator
Jens Rikardt Andersen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary continous blood glucose flash glucose monitor on the upper arm 4 weeks
Secondary C-peptide plasma concentration 4 weeks
Secondary HOMA-IR calculated glucose load test 4 weeks
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