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

NCT ID: NCT04969159

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-03-01

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.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

no intervention

standard treatment in the clinical routine

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jens Rikardt Andersen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Associate Professor, Primary Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jens R Andersen, MD,MPA

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

Department of endocrinology, Slagelse Hospiatl

Slagelse, , Denmark

Countries

Denmark

Other Identifiers

insulin - sepsis

Identifier Type: -

Identifier Source: org_study_id