Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adipose tissue biopsy, Blood sampling, Questionnaire, Patient phenotyping.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.
Overview
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.
Detailed 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.
Interventions
- 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. - Other Blood sampling
From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery. - Other 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. - Other 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.
Primary outcome measures
- General characterization of adipocyte- or adipose tissue-derived extracellular vesicles [Time frame: Baseline]
- General characterization of adipose tissue- and blood immune cells [Time frame: Baseline]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Ziekenhuis Oost-Limburg — Genk
Identifiers
NCT: NCT06444646 · CTU Z-2022041