NCT04969159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

July 9, 2021

Last Update Submit

July 9, 2021

Conditions

Sepsis

Keywords

septicaemiainsulin resitancecontinous blood glucose

Outcome Measures

Primary Outcomes (1)

  • continous blood glucose

    flash glucose monitor on the upper arm

    4 weeks

Secondary Outcomes (2)

  • C-peptide

    4 weeks

  • HOMA-IR

    4 weeks

Interventions

no interventionOTHER

standard treatment in the clinical routine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adults acutely admnitted to hospital with diagnosed sepsis on bacterial basis or on basis of covid-19

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of endocrinology, Slagelse Hospiatl

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

SepsisToxemia

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jens R Andersen, MD,MPA

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Primary Investigator

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 20, 2021

Study Start

September 1, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

no plans

Locations

DK(1)