NCT04255264

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
11mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress89%
Aug 2019Jun 2027

Study Start

First participant enrolled

August 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

6.9 years

First QC Date

February 3, 2020

Last Update Submit

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

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

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

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Emma Borgeson, PhD

CONTACT

Christina Biörserud, RN, PhD

CONTACT

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

Locations