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

Obesity Clinical Trial

— EVO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06444646
• Other study ID #: CTU Z-2022041
• Status: Recruiting
• Start date: February 20, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Hasselt University
• Contact: Lisa Mennens
• Phone: +32 (0)499 / 72 29 93
• Email: lisa.mennens[@]uhasselt.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Adipose tissue biopsy
From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.
• Blood sampling
From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.
• Questionnaire
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 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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Research Foundation Flanders, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlations between possible influencing patient factors (derived by a questionnaire) and extracellular vesicle characteristics	Questions 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.	Baseline
Other	Correlations between possible influencing patient factors (derived by patient phenotyping) and extracellular vesicle characteristics	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). 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.	Baseline
Primary	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.	Baseline
Primary	General characterization of adipose tissue- and blood immune cells	Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.	Baseline