Health TrialsbyHealthPanel

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

ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorHasselt University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Caucasian adults with obesity that have a body mass index (BMI) of at least 35 kg/m² 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.

Disqualifiers

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

Trial population

Individuals with or without obesity presenting at the bariatric surgery or abdominal surgery department, respectively.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Adipose tissue biopsy

    Other intervention

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

  • Blood sampling

    Other intervention

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

  • Questionnaire

    Other intervention

    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 intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: EVO participants with obesity4 interventions
Group B: EVO participants without obesity4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

General characterization of adipose tissue- and blood immune cells

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

Time frame
Baseline

Secondary outcomes

Other outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hasselt University

Lead sponsor

Research Foundation Flanders

Collaborator

Ziekenhuis Oost-Limburg

Collaborator

Source ClinicalTrials.gov
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