NCT06444646

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Feb 2023

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2023Sep 2026

Study Start

First participant enrolled

February 20, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

February 27, 2023

Last Update Submit

September 8, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • General characterization of adipocyte- or adipose tissue-derived extracellular vesicles

    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

    Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.

    Baseline

Other Outcomes (2)

  • Correlations between possible influencing patient factors (derived by a questionnaire) and extracellular vesicle characteristics

    Baseline

  • Correlations between possible influencing patient factors (derived by patient phenotyping) and extracellular vesicle characteristics

    Baseline

Study Arms (2)

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 biopsyOther: Blood samplingOther: QuestionnaireOther: Patient phenotyping

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 biopsyOther: Blood samplingOther: QuestionnaireOther: Patient phenotyping

Interventions

Adipose tissue biopsyOTHER

From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.

EVO participants with obesityEVO participants without obesity
Blood samplingOTHER

From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.

EVO participants with obesityEVO participants without obesity
QuestionnaireOTHER

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.

EVO participants with obesityEVO participants without obesity
Patient phenotypingOTHER

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 with obesityEVO participants without obesity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood + subcutaneous/visceral adipose tissue biopsies

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Lisa Mennens

CONTACT

+32 (0)499 / 72 29 93lisa.mennens@uhasselt.be

Kenneth Verboven

CONTACT

+32(0)11 26 93 15kenneth.verboven@uhasselt.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

February 27, 2023

First Posted

June 5, 2024

Study Start

February 20, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

BE(1)