VolunteersREXNCT04256330
Cardiometabolic Health and Inflammatory Resolution
An observational study of Volunteers, run by Göteborg University at 1 site in Sweden.
Trial summary
The aim of this study is to determine how inflammatory resolution impacts cardiometabolic health and disease in subjects that are either lean (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2) or obese (>30.0 kg/m2). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Volunteers
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 23 Jan 2020to 1 Sep 2027
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Subjects are recruited either via open adds of after having indicated in previous study registers that they are interested in participating as volunteers in future studies.
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
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 is younger than 18 years (relevant for the FAINT-1 and FAINT-2 cohorts)
- 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.
Show all 14Show fewer
- The individual regularly uses medication that affects inflammatory resolution (e.g., low-dose aspirin).
- The individual uses immunosuppressive drugs (eg, 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.
Sweden1 site, 1 recruiting
- Recruiting
Gothenburg university
Gothenburg, Västra Götaland County, 41669
Emma Börgeson, PhD, +46313420000, emma.borgeson@wlab.gu.se
Per-Anders Jansson, PhD, MD, +46313420000, Per-Anders.Jansson@wlab.gu.se
About this study
Official title: Cardiometabolic Health and Inflammatory Resolution (Kardiometabol hälsa Och Inflammatorisk Resolution)
The aim of this study is to determine how inflammatory resolution impacts cardiometabolic health and disease in subjects that are either lean (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2) or obese (>30.0 kg/m2).
- Conditions
- Volunteers
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.
Inflammatory status
The inflammatory status, defined as CRP levels and ability to respond to pro-resolving therapeutics, will be studied in all 6 groups
Measured: 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start23 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256330
- Sponsor's protocol ID
- 2019-04179
- Other IDs
- 2019
- Acronym
- REX
- Status last verified
- May 2025
- First submitted
- 3 Feb 2020
- Last updated
- 8 May 2025
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Health and Inflammatory Resolution (Kardiometabol hälsa Och Inflammatorisk Resolution)
- ClinicalTrials.gov ID
- NCT04256330
- Acronym / sponsor ID
- REX / 2019-04179
- Conditions
- Volunteers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 Feb 2020 (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 this study is to determine how inflammatory resolution impacts cardiometabolic health and disease in subjects that are either lean (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2) or obese (>30.0 kg/m2).
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 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects are recruited either via open adds of after having indicated in previous study registers that they are interested in participating as volunteers in future studies.
Key inclusion criteria (2 listed)
- Informed signed consent has been obtained from the volunteer.
- The volunteer has a BMI greater than 18.5 kg/m2
Key exclusion criteria (14 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 is younger than 18 years (relevant for the FAINT-1 and FAINT-2 cohorts)
- The individual states that they have increased bleeding tendency or are using anti-coagulant (blood thinning) medication.
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
Inflammatory status
Time frame: 2027
The inflammatory status, defined as CRP levels and ability to respond to pro-resolving therapeutics, will be studied in all 6 groups
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 8 May 2025.
- Individual participant dataSharing planned: No
Related trials for Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 Volunteers, run by Göteborg University at 1 site in Sweden.
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 14 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 8 May 2025. 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 Sweden. 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 (+46313423833, emma.borgeson@wlab.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory status (time frame: 2027). 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 8 May 2025.