Adipose Inflammation and Diabetes (FAB)
FAB
Adipose Tissue Inflammation and Diabetes Development (Fettvävsinflammation Och Diabetesutveckling)
1 other identifier
observational
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedMay 6, 2025
May 1, 2025
6.9 years
February 3, 2020
May 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Inflammatory status
The inflammatory status will be studied in obese patients.
2025
Study Arms (1)
Study patients
Obese subjects scheduled to undergo abdominoplasty surgery are included. These are later classified according to metabolic status.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska university hospital
Gothenburg, Västra Götaland County, 40530, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2020
First Posted
February 5, 2020
Study Start
August 1, 2019
Primary Completion
June 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
May 6, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share