InflammationRESOLVE AUNCT06390189
Inflammatory Resolution in Cardiometabolic Health and Disease
An observational study of Inflammation and Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
The specific aim of this study is to determine molecular pathways that differentiate metabolically healthy vs unhealthy human phenotypes, and to investigate the therapeutic potential of pro-resolving lipids. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Obesity, Cardiovascular Diseases
- How many people
- 240 participants
- Where
- 1 siteDenmark
- Study dates
- 7 May 2024to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals that contact the investigators (via phone or email) and express an interest in participating in the study will be invited to an information visit, after which the individual has at least 24 hours to consider their participation. For those that are interested in the study, the investigators then proceed to schedule visit 1-5.
Who may be able to join
- Informed signed consent has been obtained from the volunteer.
- The volunteer has a BMI greater than 18.5 kg/m2
- Men and women over the age of 18 are included.
Who cannot join
- The study staff contacting a potential participant perceives that the individual has difficulty understanding the information.
- An MD determines that the individual is on too many medications to participate.
- The individual takes a medication that is approved by the MD, but he/she is not willing or not able to wait with any potential morning medication until after their fasted blood-draw.
- The individual states that they have increased bleeding tendency or are using anti-coagulant (blood thinning) medication.
- The individual has some form of chronic inflammation.
- The individual regularly uses medication that affects inflammatory resolution (e.g., low-dose aspirin).
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- The individual uses immunosuppressive drugs (e.g., methotrexate).
- The individual regularly consumes fish oils (omega 3).
- The individual has significant gastrointestinal problems.
- The individual smokes or uses chewing tobacco.
- The individual has been drinking alcohol two days before the study visit.
- The individual has tattoos or body piercings on the forearms and / or the stomach that can affect the examination.
- The individual does not follow instructions given in the research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Aarhus, Aarhus University Hospital
Aarhus, 8200
Emma Börgeson, PhD, +4593522984, emma.borgeson@biomed.au.dk
About this study
Official title: Inflammatory Resolution in Cardiometabolic Health and Disease - an Aarhus Based Cohort
The specific aim of this study is to determine molecular pathways that differentiate metabolically healthy vs unhealthy human phenotypes, and to investigate the therapeutic potential of pro-resolving lipids. Investigators will recruit volunteers that are metabolically healthy or unhealthy that fall within three BMI ranges: lean (18.-24.9 kg/m2), overweight (25.0-29.9 kg/m2) and obese (>30.0 kg/m2). Investigators hypothesize that metabolically healthy individuals have a superior endogenous capacity to regulate an inflammatory/resolving response.
- Conditions
- Inflammation, Obesity, Cardiovascular Diseases
- Medical subject headings
- Inflammation, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean and metabolically healthy | Not described | |
| Lean and metabolically unhealthy | Not described | |
| Overweight and metabolically healthy | Not described | |
| Overweight and metabolically unhealthy | Not described | |
| Obese and metabolically healthy | Not described | |
| Obese and metabolically unhealthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation and resolution status measurements in different metabolic phenotypes
Quantifiable inflammatory resolution by measurement of IL-6 cytokine levels in the acute vs the resolving phase of blister formation.
Measured: September 2028
Secondary outcomes (1)
Systemic low-grade inflammation measurement in different phenotypes
Measurement of plasma C-reactive protein
Measured: September 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start7 May 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390189
- Sponsor's protocol ID
- 1-10-72-102-23
- Acronym
- RESOLVE AU
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Resolution in Cardiometabolic Health and Disease - an Aarhus Based Cohort
- ClinicalTrials.gov ID
- NCT06390189
- Acronym / sponsor ID
- RESOLVE AU / 1-10-72-102-23
- Conditions
- Inflammation, Obesity, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 30 Apr 2024 (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 specific aim of this study is to determine molecular pathways that differentiate metabolically healthy vs unhealthy human phenotypes, and to investigate the therapeutic potential of pro-resolving lipids. Investigators will recruit volunteers that are metabolically healthy or unhealthy that fall within three BMI ranges: lean (18.-24.9 kg/m2), overweight (25.0-29.9 kg/m2) and obese (>30.0 kg/m2). Investigators hypothesize that metabolically healthy individuals have a superior endogenous capacity to regulate an inflammatory/resolving response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lean and metabolically healthy | – | – |
| Lean and metabolically unhealthy | – | – |
| Overweight and metabolically healthy | – | – |
| Overweight and metabolically unhealthy | – | – |
| Obese and metabolically healthy | – | – |
| Obese and metabolically unhealthy | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals that contact the investigators (via phone or email) and express an interest in participating in the study will be invited to an information visit, after which the individual has at least 24 hours to consider their participation. For those that are interested in the study, the investigators then proceed to schedule visit 1-5.
Key inclusion criteria (3 listed)
- Informed signed consent has been obtained from the volunteer.
- The volunteer has a BMI greater than 18.5 kg/m2
- Men and women over the age of 18 are included.
Key exclusion criteria (13 listed)
- The study staff contacting a potential participant perceives that the individual has difficulty understanding the information.
- An MD determines that the individual is on too many medications to participate.
- The individual takes a medication that is approved by the MD, but he/she is not willing or not able to wait with any potential morning medication until after their fasted blood-draw.
- The individual states that they have increased bleeding tendency or are using anti-coagulant (blood thinning) medication.
- The individual has some form of chronic inflammation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammation and resolution status measurements in different metabolic phenotypes
Time frame: September 2028
Quantifiable inflammatory resolution by measurement of IL-6 cytokine levels in the acute vs the resolving phase of blister formation.
1 secondary outcome
Systemic low-grade inflammation measurement in different phenotypes
Time frame: September 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Obesity, run by University of Aarhus 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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Börgeson, PhD (+4593522984, emma.borgeson@biomed.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation and resolution status measurements in different metabolic phenotypes (time frame: September 2028). 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 28 Jun 2024.