Clinical trial NCT06444646: Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity.
Official title: The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: Ziekenhuis Oost-Limburg
First posted: 2024-06-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with or without obesity presenting at the bariatric surgery or abdominal surgery department, respectively.

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.

Eligibility 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) - 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)

Primary outcomes:
measure: General characterization of adipocyte- or adipose tissue-derived extracellular vesicles
timeFrame: Baseline
measure: General characterization of adipose tissue- and blood immune cells
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Correlations between possible influencing patient factors (derived by a questionnaire) and extracellular vesicle characteristics
timeFrame: Baseline
measure: Correlations between possible influencing patient factors (derived by patient phenotyping) and extracellular vesicle characteristics
timeFrame: Baseline
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References: