Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity. (EVO)

September 8, 2025 updated by: prof. dr. Kenneth Verboven, Hasselt University

The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.

Our society is characterized by a strong increase in the prevalence of obesity, which often causes the development of cardiovascular and metabolic diseases such as type 2 diabetes. The way(s) obesity is responsible for these diseases, is still insufficiently understood. This study therefore examines the content of human fat tissue storage location- and cell type-specific extracellular vesicles (EVs) in lean and obese individuals, and the possible connection with sex, insulin sensitivity, and the blood-brain barrier.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study focuses on unraveling the fundamental differences in communication via extracellular vesicles (EVs) derived from fat cells and immune cells in terms of fat tissue storage location and sex among individuals with and without obesity. The study hypothesizes that the differences in EV profiles, originating from corresponding in vitro differentiated hMADS and ex vivo isolated adult fat cells and immune cells, among individuals with and without obesity can be related to sex and/or fat tissue storage location. Additionally, the effect of the isolated EVs on the blood-brain barrier function is also investigated.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg
        • Contact:
        • Sub-Investigator:
          • Daphne Lintsen, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals with or without obesity presenting at the bariatric surgery or abdominal surgery department, respectively.

Description

Individuals with obesity - Inclusion Criteria:

  • Caucasian adults with obesity that have a body mass index (BMI) of at least 35 kg/m^2 and are scheduled for their first bariatric surgery.
  • Final male/female ratio of this study is 1:1
  • Minimal knowledge of Dutch to read and understand the informed consent.

Individuals with obesity - Exclusion Criteria:

  • Smoking and/or drug abuse
  • Cardiovascular diseases (including but not limited to implanted aids like a pacemaker or defibrillator)
  • Lung and/or kidney diseases
  • Brain and/or nerve diseases
  • Malignant diseases (e.g. cancer)

Individuals without obesity (lean) - inclusion criteria

  • Caucasian adults with obesity that have a body mass index (BMI) of between 18 and 24.9 kg/m^2 and are scheduled for abdominal surgery
  • Female only
  • Minimal knowledge of Dutch to read and understand the informed consent.

Individuals without obesity (lean) - exclusion criteria

  • Smoking and/or drug abuse
  • Cardiovascular diseases (including but not limited to implanted aids like a pacemaker or defibrillator)
  • Lung and/or kidney diseases
  • Brain and/or nerve diseases
  • Endocrine diseases like type 2 diabetes
  • Malignant diseases (e.g. cancer)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EVO participants with obesity
From each patient, two adipose tissue biopsies will be taken during bariatric surgery; one from the subcutaneous and one from the visceral adipose tissue.
Other: Adipose tissue biopsy
From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.
Other: Blood sampling
From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.
Other: Questionnaire
Before bariatric surgery, every patient will fill out questions about general health (physical activity, sedentary behavior, sleeping pattern, ...), physical condition before surgery (nausea, food intake, ...), etc.
Other: Patient phenotyping
Length and weight will be measured to calculate body mass index (BMI). Waist and hip circumference will be assessed, as well as blood pressure (both systolic and diastolic) and heart rate at rest. Body composition will be determined using a bioelectrical impedance analysis (BIA) in the hospital. Medication use and comorbidities (that are allowed within the in-/exclusion criteria) will also be derived from the patient's medical files with patient's permission.
EVO participants without obesity
From each lean patient, two adipose tissue biopsies will be taken during abdominal surgery; one from the subcutaneous and one from the visceral adipose tissue.
Other: Adipose tissue biopsy
From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.
Other: Blood sampling
From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.
Other: Questionnaire
Before bariatric surgery, every patient will fill out questions about general health (physical activity, sedentary behavior, sleeping pattern, ...), physical condition before surgery (nausea, food intake, ...), etc.
Other: Patient phenotyping
Length and weight will be measured to calculate body mass index (BMI). Waist and hip circumference will be assessed, as well as blood pressure (both systolic and diastolic) and heart rate at rest. Body composition will be determined using a bioelectrical impedance analysis (BIA) in the hospital. Medication use and comorbidities (that are allowed within the in-/exclusion criteria) will also be derived from the patient's medical files with patient's permission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General characterization of adipocyte- or adipose tissue-derived extracellular vesicles
Time Frame: Baseline
Concentration, size, surface markers, content and morphology of extracellular vesicles derived from isolated mature adipocytes, isolated adipose tissue stem cells or isolated from complete adipose tissue explants derived from both the subcutaneous as the visceral adipose tissue biopsies will be investigated.
Baseline
General characterization of adipose tissue- and blood immune cells
Time Frame: Baseline
Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between possible influencing patient factors (derived by a questionnaire) and extracellular vesicle characteristics
Time Frame: Baseline
Questions about general health (physical activity, sedentary behavior, sleeping pattern, ...), physical condition before surgery (nausea, food intake, ...), etc. This information will be used to make correlations with extracellular vesicles characteristics.
Baseline
Correlations between possible influencing patient factors (derived by patient phenotyping) and extracellular vesicle characteristics
Time Frame: Baseline
Length and weight will be measured to calculate body mass index (BMI). Waist and hip circumference will be assessed, as well as blood pressure (both systolic and diastolic) and heart rate at rest. Body composition will be determined using a bioelectrical impedance analysis (BIA). Medicine use and comorbidities (that are allowed within the in-/exclusion criteria) will also be derived from the patient's medical files with patient's permission. This information will be used to make correlations with extracellular vesicles characteristics.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

Ziekenhuis Oost-Limburg
Research Foundation Flanders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTU Z-2022041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient information will be coded based on unique identifiers. This file will only be available for the principle investigator and will be stored safely on the secured Google Enterprise drive of UHasselt. Biological samples will be processed and coded by UHasselt, after registration in the biobank of Limburg (UBILIM). Only researchers of the EVO study will have access to any of the files, patient information or biological samples.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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