[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550251":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":42,"overallOfficials":16,"centralContacts":59,"locations":69,"responsibleParty":91,"collaborators":95,"id":99,"slug":16,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":16,"studyType":113,"phases":16,"briefSummary":114,"conditions":115,"keywords":16,"overallStatus":72,"whyStopped":16,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Hasselt University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline",{"measure":14,"description":15,"timeFrame":12},"General characterization of adipose tissue- and blood immune cells","Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.",null,[18,21],{"measure":19,"description":20,"timeFrame":12},"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.",{"measure":22,"description":23,"timeFrame":12},"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-\u002Fexclusion 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.",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":25,"timePerspective":26,"maskingInfo":16},"COHORT","CROSS_SECTIONAL","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\u002For fat tissue storage location. Additionally, the effect of the isolated EVs on the blood-brain barrier function is also investigated.","Individuals with or without obesity presenting at the bariatric surgery or abdominal surgery department, respectively.",[30,38],{"label":31,"type":16,"description":32,"interventionNames":33},"EVO participants with obesity","From each patient, two adipose tissue biopsies will be taken during bariatric surgery; one from the subcutaneous and one from the visceral adipose tissue.",[34,35,36,37],"Other: Adipose tissue biopsy","Other: Blood sampling","Other: Questionnaire","Other: Patient phenotyping",{"label":39,"type":16,"description":40,"interventionNames":41},"EVO participants without obesity","From each lean patient, two adipose tissue biopsies will be taken during abdominal surgery; one from the subcutaneous and one from the visceral adipose tissue.",[34,35,36,37],[43,47,51,55],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":16},"Adipose tissue biopsy","From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.",[31,39],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":16},"Blood sampling","From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.",[31,39],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":16},"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.",[31,39],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":16},"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-\u002Fexclusion criteria) will also be derived from the patient's medical files with patient's permission.",[31,39],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":16,"email":64},"Lisa Mennens","CONTACT","+32 (0)499 \u002F 72 29 93","lisa.mennens@uhasselt.be",{"name":66,"role":62,"phone":67,"phoneExt":16,"email":68},"Kenneth Verboven","+32(0)11 26 93 15","kenneth.verboven@uhasselt.be",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Ziekenhuis Oost-Limburg","RECRUITING","Genk","Limburg","3600","Belgium","BE",{"type":79,"coordinates":80},"Point",[81,82],5.50082,50.965,{"lat":82,"lon":81},[85,88],{"name":86,"role":62,"phone":16,"phoneExt":16,"email":87},"Lisa Mennens, MSc","lisamennens@uhasselt.be",{"name":89,"role":90,"phone":16,"phoneExt":16,"email":16},"Daphne Lintsen, MSc","SUB_INVESTIGATOR",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","prof. dr. Kenneth Verboven","Prof. dr.",[96,98],{"name":97,"class":6},"Research Foundation Flanders",{"name":71,"class":6},"100550251",false,"NCT06444646","Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity.","The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.","EVO","Individuals with obesity - Inclusion Criteria:\n\n* Caucasian adults with obesity that have a body mass index (BMI) of at least 35 kg\u002Fm\\^2 and are scheduled for their first bariatric surgery.\n* Final male\u002Ffemale ratio of this study is 1:1\n* Minimal knowledge of Dutch to read and understand the informed consent.\n\nIndividuals with obesity - Exclusion Criteria:\n\n* Smoking and\u002For drug abuse\n* Cardiovascular diseases (including but not limited to implanted aids like a pacemaker or defibrillator)\n* Lung and\u002For kidney diseases\n* Brain and\u002For nerve diseases\n* Malignant diseases (e.g. cancer)\n\nIndividuals without obesity (lean) - inclusion criteria\n\n* Caucasian adults with obesity that have a body mass index (BMI) of between 18 and 24.9 kg\u002Fm\\^2 and are scheduled for abdominal surgery\n* Female only\n* Minimal knowledge of Dutch to read and understand the informed consent.\n\nIndividuals without obesity (lean) - exclusion criteria\n\n* Smoking and\u002For drug abuse\n* Cardiovascular diseases (including but not limited to implanted aids like a pacemaker or defibrillator)\n* Lung and\u002For kidney diseases\n* Brain and\u002For nerve diseases\n* Endocrine diseases like type 2 diabetes\n* Malignant diseases (e.g. cancer)",true,"ALL","18 Years","65 Years",{"count":111,"type":112},150,"ESTIMATED","OBSERVATIONAL","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.",[116],"Obesity","2025-09-08",{"date":119,"type":120},"2025-09-15","ACTUAL",{"date":122,"type":120},"2023-02-20",{"date":124,"type":112},"2026-09",{"name":5,"class":6},1]