Clinical trial NCT05867524: Characterization of Natural IL-6 Inhibition in Healthy Individuals
Official title: Characterization of Natural IL-6 Inhibition in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autoantibodies
Interleukin-6
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Clinical Immunological Department, Rigshospitalet
name: The Danish Blood Donor Study
First posted: 2023-05-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Groups defined by autoantibodies status (high or low)
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the project is to investigate whether or not there are any difference in cardiometabolic outcomes in individuals with high or low levels of c-aAb against interleukin-6 (IL-6).

The study is the first to investigate individuals with extreme amounts of c-aAb levels against IL-6 and to contribute with knowledge on a possible new phenotype.


Eligibility criteria: Inclusion Criteria:

* Fulfill Danish blood donor criteria
* Have extreme amounts of IL-6 c-aAb or matched as control (low amounts of IL-6 c-aAb)

Exclusion Criteria:

* Failure to fulfill Danish blood donor criteria

Primary outcomes:
measure: Inflammatory markers
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Whole-body glucose metabolism
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Whole-body glucose metabolism
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Whole-body glucose metabolism
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Whole-body glucose metabolism
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Whole-body glucose metabolism
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Cardiovascular risk markers
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Cardiovascular risk markers
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Cardiovascular risk markers
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Cardiovascular risk markers
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Difference in exercise response
timeFrame: Measurements over a two-hour cycling test, and one hour of recovery
measure: Difference in exercise response
timeFrame: Measurements over a two-hour cycling test, and one hour of recovery
measure: Difference in exercise response
timeFrame: Measurements over a two-hour cycling test, and one hour of recovery
measure: Difference in exercise response
timeFrame: Measurements over a two-hour cycling test, and one hour of recovery
measure: Metabolic response during exercise
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Metabolic response during exercise
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Metabolic response during exercise
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Metabolic response during exercise
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Metabolic response during exercise
timeFrame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
measure: Metabolic assessment of the liver
timeFrame: An MRI-scanning withinn four weeks of the oral glucose tolerance test
measure: Metabolic assessment of the liver
timeFrame: An MRI-scanning withinn four weeks of the oral glucose tolerance test
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
Study officials:
affiliation: University of Copenhagen
name: Torben Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: