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Characterization of Natural IL-6 Inhibition in Healthy Individuals

Characterization of Natural IL-6 Inhibition in Healthy Individuals

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05867524
Acronym
FIDI
Enrollment
40
Registered
2023-05-22
Start date
2022-11-01
Completion date
2024-02-01
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoantibodies, Interleukin-6

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.

Interventions

OTHEROral Glucose Tolerance Test

75g oral glucose tolerance test, sampled over three hours

2 hours of moderate activity level cycling

Sponsors

Clinical Immunological Department, Rigshospitalet
CollaboratorUNKNOWN
The Danish Blood Donor Study
CollaboratorUNKNOWN
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Groups defined by autoantibodies status (high or low)

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Inflammatory markersMeasurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recoveryIL-6 plasma levels, plasma IL-6 c-aAb levels
Whole-body glucose metabolismMeasurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recoveryPlasma levels of: Insulin
Cardiovascular risk markersMeasurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recoveryLipids
Difference in exercise responseMeasurements over a two-hour cycling test, and one hour of recovery2-hour Lactate
Metabolic response during exerciseMeasurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery2-hour glucose
Metabolic assessment of the liverAn MRI-scanning withinn four weeks of the oral glucose tolerance testLiver fat content from MRI-scanning, and HOMA-IR

Countries

Denmark

Contacts

Primary ContactTorben Hansen, PhD
torben.hansen@sund.ku.dk20565301
Backup ContactRasmus T Jensen, MSc
rasmus.tanderup@sund.ku.dk24429252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026