Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06444646
Acronym
EVO
Enrollment
150
Registered
2024-06-05
Start date
2023-02-20
Completion date
2026-09-30
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

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.

Interventions

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

OTHERBlood sampling

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

OTHERQuestionnaire

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.

OTHERPatient 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.

Sponsors

Research Foundation Flanders
CollaboratorOTHER
Ziekenhuis Oost-Limburg
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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) -

Design outcomes

Primary

MeasureTime frameDescription
General characterization of adipocyte- or adipose tissue-derived extracellular vesiclesBaselineConcentration, 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 cellsBaselineImmune cells isolated from adipose tissue and blood will be characterized by flow cytometry.

Other

MeasureTime frameDescription
Correlations between possible influencing patient factors (derived by a questionnaire) and extracellular vesicle characteristicsBaselineQuestions 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.
Correlations between possible influencing patient factors (derived by patient phenotyping) and extracellular vesicle characteristicsBaselineLength 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.

Countries

Belgium

Contacts

Primary ContactLisa Mennens
lisa.mennens@uhasselt.be+32 (0)499 / 72 29 93
Backup ContactKenneth Verboven
kenneth.verboven@uhasselt.be+32(0)11 26 93 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026