FIDI: Characterization of Natural IL-6 Inhibition in Healthy Individuals

• Sponsor: University of Copenhagen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05867524
• Collaborator: Clinical Immunological Department, Rigshospitalet (Other), The Danish Blood Donor Study (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoantibodies; Interleukin-6	Other: Oral Glucose Tolerance Test; Other: Cycling test	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Groups defined by autoantibodies status (high or low)Groups defined by autoantibodies status (high or low)
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Characterization of Natural IL-6 Inhibition in Healthy Individuals
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High IL-6 c-aAb Individuals with top percentile IL-6 c-aAb	Other: Oral Glucose Tolerance Test; 75g oral glucose tolerance test, sampled over three hours; Other: Cycling test; 2 hours of moderate activity level cycling
Experimental: Low IL-6 c-aAb Individually matched controls with low IL-6 c-aAb	Other: Oral Glucose Tolerance Test; 75g oral glucose tolerance test, sampled over three hours; Other: Cycling test; 2 hours of moderate activity level cycling

Outcome Measures

Primary Outcome Measures

1. 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

2. 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: Insulin

3. 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: C-peptide

4. 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: Glucose

5. 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: GLP-1

6. 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

7. Cardiovascular risk markers [Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery]

   Lipids

8. Cardiovascular risk markers [Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery]

   Triglyceride

9. Cardiovascular risk markers [Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery]

   Blood pressure

10. 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

11. Difference in exercise response [Measurements over a two-hour cycling test, and one hour of recovery]

    2-hour Lactate

12. Difference in exercise response [Measurements over a two-hour cycling test, and one hour of recovery]

    2-hour epinephrine

13. Difference in exercise response [Measurements over a two-hour cycling test, and one hour of recovery]

    2-hour norepinephrine

14. Difference in exercise response [Measurements over a two-hour cycling test, and one hour of recovery]

    Peak IL-6

15. Metabolic response during exercise [Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery]

    2-hour glucose

16. Metabolic response during exercise [Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery]

    2-hour glucagon

17. Metabolic response during exercise [Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery]

    2-hour insulin

18. Metabolic response during exercise [Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery]

    2-hour lipids

19. Metabolic response during exercise [Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery]

    Triglyceride

20. Metabolic assessment of the liver [An MRI-scanning withinn four weeks of the oral glucose tolerance test]

    Liver fat content from MRI-scanning, and HOMA-IR

21. Metabolic assessment of the liver [An MRI-scanning withinn four weeks of the oral glucose tolerance test]

    HOMA-IR

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Frederiksberg Hospital	Frederiksberg		Denmark	2000

Sponsors and Collaborators

• University of Copenhagen
• Clinical Immunological Department, Rigshospitalet
• The Danish Blood Donor Study

Investigators

• Principal Investigator: Torben Hansen, PhD, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Torben Hansen, Professor, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT05867524
• Other Study ID Numbers: H-20082776
• First Posted: May 22, 2023
• Last Update Posted: May 22, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 22, 2023