Characterization of Natural IL-6 Inhibition in Healthy Individuals

Not Applicable

Recruiting

• Conditions: Autoantibodies; Interleukin-6
• Interventions: Other: Oral Glucose Tolerance Test; Other: Cycling test

• Registration Number: NCT05867524
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-01-27
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low IL-6 c-aAb	Cycling test	Individually matched controls with low IL-6 c-aAb
Low IL-6 c-aAb	Oral Glucose Tolerance Test	Individually matched controls with low IL-6 c-aAb
High IL-6 c-aAb	Cycling test	Individuals with top percentile IL-6 c-aAb
High IL-6 c-aAb	Oral Glucose Tolerance Test	Individuals with top percentile IL-6 c-aAb

Primary Outcome Measures

Name	Time	Method
Inflammatory markers	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	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery	Plasma levels of: GIPR
Cardiovascular risk markers	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery	Epicardial adipose tissue
Difference in exercise response	Measurements over a two-hour cycling test, and one hour of recovery	Peak IL-6
Metabolic response during exercise	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery	Triglyceride
Metabolic assessment of the liver	An MRI-scanning withinn four weeks of the oral glucose tolerance test	HOMA-IR

Trial Locations

Locations (1)

Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark