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

Recruiting

• Conditions: Obesity
• Interventions: Other: Adipose tissue biopsy; Other: Blood sampling; Other: Questionnaire; Other: Patient phenotyping

• Registration Number: NCT06444646
• Lead Sponsor: Hasselt University

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.

Study Timeline

• Study Start: 2023-02-20
• Study First Submitted: 2023-02-27
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-05
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EVO participants without obesity	Patient phenotyping	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.
EVO participants with obesity	Blood sampling	From 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	Adipose tissue biopsy	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.
EVO participants without obesity	Blood sampling	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.
EVO participants with obesity	Questionnaire	From 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 with obesity	Adipose tissue biopsy	From 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 with obesity	Patient phenotyping	From 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	Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
General characterization of adipocyte- or adipose tissue-derived extracellular vesicles	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	Baseline	Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium