Characterization of Natural IL-6 Inhibition in Healthy Individuals

NCT ID: NCT05867524

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-02-01

Brief Summary

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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

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Conditions

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Autoantibodies Interleukin-6

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Groups defined by autoantibodies status (high or low)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High IL-6 c-aAb

Individuals with top percentile IL-6 c-aAb

Group Type EXPERIMENTAL

Oral Glucose Tolerance Test

Intervention Type OTHER

75g oral glucose tolerance test, sampled over three hours

Cycling test

Intervention Type OTHER

2 hours of moderate activity level cycling

Low IL-6 c-aAb

Individually matched controls with low IL-6 c-aAb

Group Type EXPERIMENTAL

Oral Glucose Tolerance Test

Intervention Type OTHER

75g oral glucose tolerance test, sampled over three hours

Cycling test

Intervention Type OTHER

2 hours of moderate activity level cycling

Interventions

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Oral Glucose Tolerance Test

75g oral glucose tolerance test, sampled over three hours

Intervention Type OTHER

Cycling test

2 hours of moderate activity level cycling

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinical Immunological Department, Rigshospitalet

UNKNOWN

Sponsor Role collaborator

The Danish Blood Donor Study

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Torben Hansen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Torben Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Frederiksberg Hospital

Frederiksberg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Torben Hansen, PhD

Role: CONTACT

20565301 ext. +45

Rasmus T Jensen, MSc

Role: CONTACT

24429252 ext. +45

Facility Contacts

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Rasmus T Jensen, Msc

Role: primary

24 42 92 52

Other Identifiers

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H-20082776

Identifier Type: -

Identifier Source: org_study_id

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