Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06444646

Recruiting nowNot applicableObservational

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry 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)

Treatments and study arms

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

General characterization of adipocyte- or adipose tissue-derived extracellular vesiclesBaseline

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 cellsBaseline

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ziekenhuis Oost-Limburg🇧🇪 Genk, Limburg, Belgium

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Lisa Mennens, MScContact

Daphne Lintsen, MScSub Investigator