Characterization of Natural IL-6 Inhibition in Healthy Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Copenhagen
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Inflammatory markers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Inflammatory markers
Time Frame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
IL-6 plasma levels, plasma IL-6 c-aAb levels
Whole-body glucose metabolism
Time Frame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Plasma levels of: Insulin
Cardiovascular risk markers
Time Frame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Lipids
Difference in exercise response
Time Frame: Measurements over a two-hour cycling test, and one hour of recovery
2-hour Lactate
Metabolic response during exercise
Time Frame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
2-hour glucose
Metabolic assessment of the liver
Time Frame: An MRI-scanning withinn four weeks of the oral glucose tolerance test
Liver fat content from MRI-scanning, and HOMA-IR
Secondary Outcomes
No secondary outcomes reported
Investigators
Torben Hansen
Professor
University of Copenhagen