ObesityEVONCT06444646
Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity.
An observational study of Obesity, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Adipose tissue biopsy, Blood sampling and Questionnaire
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Feb 2023to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with or without obesity presenting at the bariatric surgery or abdominal surgery department, respectively.
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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Lisa Mennens, MSc, lisamennens@uhasselt.be
Daphne Lintsen, MSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Adipose tissue biopsy, Blood sampling, Questionnaire, Patient phenotyping
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue biopsyOther
From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.
Blood samplingOther
From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Adipose tissue biopsy; Other: Blood sampling; Other: Questionnaire; Other: 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. Receives: Other: Adipose tissue biopsy; Other: Blood sampling; Other: Questionnaire; Other: Patient phenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
General characterization of adipose tissue- and blood immune cells
Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start20 Feb 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, prof. dr. Kenneth Verboven, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444646
- Sponsor's protocol ID
- CTU Z-2022041
- Acronym
- EVO
- Status last verified
- Sep 2025
- First submitted
- 27 Feb 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.
- ClinicalTrials.gov ID
- NCT06444646
- Acronym / sponsor ID
- EVO / CTU Z-2022041
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, Ziekenhuis Oost-Limburg
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVO participants with obesity | – | Other: Adipose tissue biopsy, Other: Blood sampling, Other: Questionnaire, Other: Patient phenotypingFrom each patient, two adipose tissue biopsies will be taken during bariatric surgery; one from the subcutaneous and one from the visceral adipose tissue. |
| EVO participants without obesity | – | Other: Adipose tissue biopsy, Other: Blood sampling, Other: Questionnaire, Other: Patient phenotypingFrom each lean patient, two adipose tissue biopsies will be taken during abdominal surgery; one from the subcutaneous and one from the visceral adipose tissue. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with or without obesity presenting at the bariatric surgery or abdominal surgery department, respectively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose tissue biopsyFrom each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue. | Other | EVO participants with obesity, EVO participants without obesity |
| Blood samplingFrom each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery. | Other | EVO participants with obesity, EVO participants without obesity |
| QuestionnaireBefore 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 | EVO participants with obesity, EVO participants without obesity |
| Patient phenotypingLength 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. | Other | EVO participants with obesity, EVO participants without obesity |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Mennens (+32 (0)499 / 72 29 93, lisa.mennens@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General characterization of adipocyte- or adipose tissue-derived extracellular vesicles (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.