Characterization of Natural IL-6 Inhibition in Healthy Individuals (FIDI)

May 10, 2023 updated by: Torben Hansen, University of Copenhagen

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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: C-peptide
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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: Glucose
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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: GLP-1
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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: GIPR
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Cardiovascular risk markers
Time Frame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Triglyceride
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Cardiovascular risk markers
Time Frame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Blood pressure
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Cardiovascular risk markers
Time Frame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Epicardial adipose tissue
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Difference in exercise response
Time Frame: Measurements over a two-hour cycling test, and one hour of recovery
2-hour Lactate
Measurements over a two-hour cycling test, and one hour of recovery
Difference in exercise response
Time Frame: Measurements over a two-hour cycling test, and one hour of recovery
2-hour epinephrine
Measurements over a two-hour cycling test, and one hour of recovery
Difference in exercise response
Time Frame: Measurements over a two-hour cycling test, and one hour of recovery
2-hour norepinephrine
Measurements over a two-hour cycling test, and one hour of recovery
Difference in exercise response
Time Frame: Measurements over a two-hour cycling test, and one hour of recovery
Peak IL-6
Measurements over a two-hour cycling test, and one hour of recovery
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
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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 glucagon
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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 insulin
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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 lipids
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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
Triglyceride
Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
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
An MRI-scanning withinn four weeks of the oral glucose tolerance test
Metabolic assessment of the liver
Time Frame: An MRI-scanning withinn four weeks of the oral glucose tolerance test
HOMA-IR
An MRI-scanning withinn four weeks of the oral glucose tolerance test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Clinical Immunological Department, Rigshospitalet
The Danish Blood Donor Study

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • H-20082776

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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