NCT05867524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

January 27, 2023

Last Update Submit

May 10, 2023

Conditions

AutoantibodiesInterleukin-6

Outcome Measures

Primary Outcomes (21)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Cardiovascular risk markers

    Lipids

    Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery

  • Cardiovascular risk markers

    Triglyceride

    Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery

  • Cardiovascular risk markers

    Blood pressure

    Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery

  • 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

  • Difference in exercise response

    2-hour Lactate

    Measurements over a two-hour cycling test, and one hour of recovery

  • Difference in exercise response

    2-hour epinephrine

    Measurements over a two-hour cycling test, and one hour of recovery

  • Difference in exercise response

    2-hour norepinephrine

    Measurements over a two-hour cycling test, and one hour of recovery

  • Difference in exercise response

    Peak IL-6

    Measurements over a two-hour cycling test, and one hour of recovery

  • 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

  • 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

  • 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

  • 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

  • Metabolic response during exercise

    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

    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

    HOMA-IR

    An MRI-scanning withinn four weeks of the oral glucose tolerance test

Study Arms (2)

High IL-6 c-aAb

EXPERIMENTAL

Individuals with top percentile IL-6 c-aAb

Other: Oral Glucose Tolerance TestOther: Cycling test

Low IL-6 c-aAb

EXPERIMENTAL

Individually matched controls with low IL-6 c-aAb

Other: Oral Glucose Tolerance TestOther: Cycling test

Interventions

Oral Glucose Tolerance TestOTHER

75g oral glucose tolerance test, sampled over three hours

High IL-6 c-aAbLow IL-6 c-aAb
Cycling testOTHER

2 hours of moderate activity level cycling

High IL-6 c-aAbLow IL-6 c-aAb

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfill Danish blood donor criteria
  • Have extreme amounts of IL-6 c-aAb or matched as control (low amounts of IL-6 c-aAb)

You may not qualify if:

  • Failure to fulfill Danish blood donor criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

RECRUITING

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Torben Hansen, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Torben Hansen, PhD

CONTACT

20565301torben.hansen@sund.ku.dk

Rasmus T Jensen, MSc

CONTACT

24429252rasmus.tanderup@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Groups defined by autoantibodies status (high or low)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2023

First Posted

May 22, 2023

Study Start

November 1, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)