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

Hasselt University

Status: Enrolling

Conditions: Obesity

Treatments: Other: Questionnaire; Other: Blood sampling; Other: Adipose tissue biopsy; Other: Patient phenotyping

Study type: Observational

Funder types: Other

Identifiers

NCT06444646

CTU Z-2022041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

150 participants in 2 patient groups

EVO participants with obesity

Description:

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

Treatment:

Other: Patient phenotyping

Other: Adipose tissue biopsy

Other: Blood sampling

Other: Questionnaire

EVO participants without obesity

Description:

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.

Treatment:

Other: Patient phenotyping

Other: Adipose tissue biopsy

Other: Blood sampling

Other: Questionnaire