AutoantibodiesFIDINCT05867524
Characterization of Natural IL-6 Inhibition in Healthy Individuals
A study testing Oral Glucose Tolerance Test and Cycling test in people with Autoantibodies and Interleukin-6, run by University of Copenhagen at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autoantibodies, Interleukin-6
- What is being tested?
- Oral Glucose Tolerance Test and Cycling test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Fulfill Danish blood donor criteria
- Have extreme amounts of IL-6 c-aAb or matched as control (low amounts of IL-6 c-aAb)
Who cannot join
- Failure to fulfill Danish blood donor criteria
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Frederiksberg Hospital
Frederiksberg, 2000
Rasmus T Jensen, Msc, 24 42 92 52, rasmus.tanderup@sund.ku.dk
About this study
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.
- Conditions
- Autoantibodies, Interleukin-6
- Being tested
- Oral Glucose Tolerance Test, Cycling test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance TestOther
75g oral glucose tolerance test, sampled over three hours
Cycling testOther
2 hours of moderate activity level cycling
| Study group | Role | What they receive |
|---|---|---|
| High IL-6 c-aAb | Experimental | Individuals with top percentile IL-6 c-aAb Receives: Other: Oral Glucose Tolerance Test; Other: Cycling test |
| Low IL-6 c-aAb | Experimental | Individually matched controls with low IL-6 c-aAb Receives: Other: Oral Glucose Tolerance Test; Other: Cycling test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
IL-6 plasma levels, plasma IL-6 c-aAb levels
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Cardiovascular risk markers
Lipids
Measured: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Cardiovascular risk markers
Triglyceride
Measured: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Cardiovascular risk markers
Blood pressure
Measured: 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
Measured: 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
Measured: Measurements over a two-hour cycling test, and one hour of recovery
Difference in exercise response
2-hour epinephrine
Measured: Measurements over a two-hour cycling test, and one hour of recovery
Difference in exercise response
2-hour norepinephrine
Measured: Measurements over a two-hour cycling test, and one hour of recovery
Difference in exercise response
Peak IL-6
Measured: Measurements over a two-hour cycling test, and one hour of recovery
Metabolic response during exercise
2-hour glucose
Measured: 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
Measured: 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
Measured: 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
Measured: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Metabolic response during exercise
Triglyceride
Measured: 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
Measured: An MRI-scanning withinn four weeks of the oral glucose tolerance test
Metabolic assessment of the liver
HOMA-IR
Measured: An MRI-scanning withinn four weeks of the oral glucose tolerance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Nov 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutoantibodiesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Groups defined by autoantibodies status (high or low)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Immunological Department, Rigshospitalet, The Danish Blood Donor Study
- Responsible party
- Principal investigator, Torben Hansen, University of Copenhagen
- Investigators
- Torben Hansen, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867524
- Sponsor's protocol ID
- H-20082776
- Acronym
- FIDI
- Status last verified
- May 2023
- First submitted
- 27 Jan 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Natural IL-6 Inhibition in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05867524
- Acronym / sponsor ID
- FIDI / H-20082776
- Conditions
- Autoantibodies, Interleukin-6
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Clinical Immunological Department, Rigshospitalet, The Danish Blood Donor Study
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Groups defined by autoantibodies status (high or low)
| Arm | Type | Receives |
|---|---|---|
| High IL-6 c-aAb | Experimental | Other: Oral Glucose Tolerance Test, Other: Cycling testIndividuals with top percentile IL-6 c-aAb |
| Low IL-6 c-aAb | Experimental | Other: Oral Glucose Tolerance Test, Other: Cycling testIndividually matched controls with low IL-6 c-aAb |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Fulfill Danish blood donor criteria
- Have extreme amounts of IL-6 c-aAb or matched as control (low amounts of IL-6 c-aAb)
Key exclusion criteria (1 listed)
- Failure to fulfill Danish blood donor criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Tolerance Test75g oral glucose tolerance test, sampled over three hours | Other | High IL-6 c-aAb, Low IL-6 c-aAb |
| Cycling test2 hours of moderate activity level cycling | Other | High IL-6 c-aAb, Low IL-6 c-aAb |
Primary outcome
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
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
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
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
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
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
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
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
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
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
Difference in exercise response
Time frame: Measurements over a two-hour cycling test, and one hour of recovery
2-hour Lactate
Difference in exercise response
Time frame: Measurements over a two-hour cycling test, and one hour of recovery
2-hour epinephrine
Difference in exercise response
Time frame: Measurements over a two-hour cycling test, and one hour of recovery
2-hour norepinephrine
Difference in exercise response
Time frame: Measurements over a two-hour cycling test, and one hour of recovery
Peak IL-6
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
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
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
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
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
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
Metabolic assessment of the liver
Time frame: An MRI-scanning withinn four weeks of the oral glucose tolerance test
HOMA-IR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torben Hansen, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance Test and Cycling test in people with Autoantibodies and Interleukin-6, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Torben Hansen, PhD (20565301 ext. +45, torben.hansen@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers (time frame: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.