Characterization of Natural IL-6 Inhibition in Healthy Individuals

Interleukin-6 Clinical Trial

— FIDI  

Official title:

Characterization of Natural IL-6 Inhibition in Healthy Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867524
• Other study ID #: H-20082776
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2023
• Source: University of Copenhagen
• Contact: Torben Hansen, PhD
• Phone: 20565301
• Email: torben.hansen[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Autoantibodies
• Interleukin-6

Intervention

Other:
• Oral Glucose Tolerance Test
75g oral glucose tolerance test, sampled over three hours
• Cycling test
2 hours of moderate activity level cycling

Locations

Country	Name	City	State
Denmark	Frederiksberg Hospital	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Clinical Immunological Department, Rigshospitalet, The Danish Blood Donor Study

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers	IL-6 plasma levels, plasma IL-6 c-aAb levels	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Whole-body glucose metabolism	Plasma levels of: Insulin	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Whole-body glucose metabolism	Plasma levels of: C-peptide	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Whole-body glucose metabolism	Plasma levels of: Glucose	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Whole-body glucose metabolism	Plasma levels of: GLP-1	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Whole-body glucose metabolism	Plasma levels of: GIPR	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Cardiovascular risk markers	Lipids	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Cardiovascular risk markers	Triglyceride	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Cardiovascular risk markers	Blood pressure	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Cardiovascular risk markers	Epicardial adipose tissue	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Difference in exercise response	2-hour Lactate	Measurements over a two-hour cycling test, and one hour of recovery
Primary	Difference in exercise response	2-hour epinephrine	Measurements over a two-hour cycling test, and one hour of recovery
Primary	Difference in exercise response	2-hour norepinephrine	Measurements over a two-hour cycling test, and one hour of recovery
Primary	Difference in exercise response	Peak IL-6	Measurements over a two-hour cycling test, and one hour of recovery
Primary	Metabolic response during exercise	2-hour glucose	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Metabolic response during exercise	2-hour glucagon	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Metabolic response during exercise	2-hour insulin	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Metabolic response during exercise	2-hour lipids	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Metabolic response during exercise	Triglyceride	Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Primary	Metabolic assessment of the liver	Liver fat content from MRI-scanning, and HOMA-IR	An MRI-scanning withinn four weeks of the oral glucose tolerance test
Primary	Metabolic assessment of the liver	HOMA-IR	An MRI-scanning withinn four weeks of the oral glucose tolerance test