Adipose Inflammation and Diabetes (FAB) (FAB)

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.

Study Overview

• Status: Unknown
• Conditions: Obese

• Study Type: Observational
• Enrollment (Anticipated): 18

Contacts and Locations

• Study Contact: Name: Emma Borgeson, PhD; Phone Number: +46313420000; Email: emma.borgeson@wlab.gu.se
• Study Contact Backup: Name: Christina Biörserud, RN, PhD; Phone Number: +46313420000; Email: christina.biorserud@vgregion.se

Study Locations

• Sweden
  • Vastra Gotaland
    • Gothenburg, Vastra Gotaland, Sweden, 40530
      • Recruiting
      • Sahlgrenska University Hospital
      • Contact: Emma Borgeson, PhD; Phone Number: +4631342000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study patients; Obese subjects scheduled to undergo abdominoplasty surgery are included. These are later classified according to metabolic status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory status	The inflammatory status will be studied in obese patients.	2025

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2019-04046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No