ObeseFABNCT04255264
Adipose Inflammation and Diabetes (FAB)
An observational study of Obese, run by Göteborg University at 1 site in Sweden.
Trial summary
The study investigates whether the addition of resolution molecules can inhibit inflammation and insulin resistance in human tissue taken from obese individuals, and whether the results of these studies correlate with patient-specific resolution phenotypes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2019to 30 Jun 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 60 years
- All sexes
- Adult
Study population: The patients participating in this study must have undergone a gastric bypass surgery >2 years ago, and currently have excess skin of > 3 cm, thus requiring an abdominoplasty surgery. We only include patients that are obese (BMI 30-40 kg/m2). Patients interested in participating in the study donate the skin and adipose tissue that is discarded during surgery. In addition, they donate blood samples prior to surgery.
Who may be able to join
- BMI 30-40 kg/m2
- Ptos (i.e. excess skin) > 3 cm
- Patient underwent gastric bypass surgery >2 years ago
- Patient has had a stable weight ≥6 months at the time of operation
- Patient does not smoke (min 6 weeks prior to surgery)
Who cannot join
- Patients who do not understand spoken and written Swedish
- American Society of Anesthesiologists (ASA) classification ≥ 3
- Neurological, orthopedic or rheumatologic injury or illness affecting physical ability
- Preoperatively known hernia requiring surgical operation
- Severe mental illness
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
Sahlgrenska university hospital
Gothenburg, Västra Götaland County, 40530
Emma Borgeson, PhD, +4631342000
About this study
Official title: Adipose Tissue Inflammation and Diabetes Development (Fettvävsinflammation Och Diabetesutveckling)
The study investigates whether the addition of resolution molecules can inhibit inflammation and insulin resistance in human tissue taken from obese individuals, and whether the results of these studies correlate with patient-specific resolution phenotypes.
- Conditions
- Obese
- Medical subject headings
- Obesity
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 |
|---|---|---|
| Study patients | Obese subjects scheduled to undergo abdominoplasty surgery are included. These are later classified according to metabolic status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory status
The inflammatory status will be studied in obese patients.
Measured: 2025
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 start1 Aug 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- 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
- 18 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
- NCT04255264
- Sponsor's protocol ID
- 2019-04046
- Other IDs
- 2019
- Acronym
- FAB
- Status last verified
- May 2025
- First submitted
- 3 Feb 2020
- Last updated
- 6 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Inflammation and Diabetes Development (Fettvävsinflammation Och Diabetesutveckling)
- ClinicalTrials.gov ID
- NCT04255264
- Acronym / sponsor ID
- FAB / 2019-04046
- Conditions
- Obese
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 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 study investigates whether the addition of resolution molecules can inhibit inflammation and insulin resistance in human tissue taken from obese individuals, and whether the results of these studies correlate with patient-specific resolution phenotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patients | – | –Obese subjects scheduled to undergo abdominoplasty surgery are included. These are later classified according to metabolic status. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The patients participating in this study must have undergone a gastric bypass surgery >2 years ago, and currently have excess skin of > 3 cm, thus requiring an abdominoplasty surgery. We only include patients that are obese (BMI 30-40 kg/m2). Patients interested in participating in the study donate the skin and adipose tissue that is discarded during surgery. In addition, they donate blood samples prior to surgery.
Key inclusion criteria (5 listed)
- BMI 30-40 kg/m2
- Ptos (i.e. excess skin) > 3 cm
- Patient underwent gastric bypass surgery >2 years ago
- Patient has had a stable weight ≥6 months at the time of operation
- Patient does not smoke (min 6 weeks prior to surgery)
Key exclusion criteria (5 listed)
- Patients who do not understand spoken and written Swedish
- American Society of Anesthesiologists (ASA) classification ≥ 3
- Neurological, orthopedic or rheumatologic injury or illness affecting physical ability
- Preoperatively known hernia requiring surgical operation
- Severe mental illness
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: 2025
The inflammatory status will be studied in obese patients.
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 6 May 2025.
- 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 Obese, 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 5 inclusion and 5 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 6 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 Borgeson, PhD (+46313420000, 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: 2025). 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 6 May 2025.