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NCT Number: NCT06444646

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location status: Recruiting

Location contact

Daphne Lintsen, MSc

SUB_INVESTIGATOR

Lisa Mennens, MSc

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

adipose tissue biopsy

Other

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

Blood sampling

Other

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

Questionnaire

Other

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

Other

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.

Primary outcomes

  1. General characterization of adipocyte- or adipose tissue-derived extracellular vesicles

    Time frame: 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.

  2. General characterization of adipose tissue- and blood immune cells

    Time frame: Baseline

    Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.

Other outcomes

  1. Correlations between possible influencing patient factors (derived by a questionnaire) and extracellular vesicle characteristics

    Time frame: Baseline

    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.

  2. Correlations between possible influencing patient factors (derived by patient phenotyping) and extracellular vesicle characteristics

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth Verboven

CONTACT

[email protected]

+32(0)11 26 93 15

Lisa Mennens

CONTACT

[email protected]

+32 (0)499 / 72 29 93

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Research Foundation Flanders
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: EVO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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