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Clinical Trials in Belgium / NCT06444646
Recruiting Observational

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

NCT06444646 · tracked via the Priya Life Science Belgium tracker
Sponsor
Hasselt University
Phase
Observational
Started
2023-02-20
Last updated
2025-09-15

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Adipose tissue biopsyBlood samplingQuestionnairePatient phenotyping

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Ziekenhuis Oost-Limburg Genk Limburg Recruiting

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Other trials for the same condition

A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin Recruiting
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity Active, not recruiting
Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery Recruiting
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight Recruiting
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06444646 on ClinicalTrials.gov ↗ ← All trials in Belgium