Ziekenhuis Oost-Limburg
Genk, Limburg, 3600, Belgium
Location status: Recruiting
NCT Number: NCT06444646
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Genk, Limburg, 3600, Belgium
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Individuals with obesity - Inclusion Criteria:
Individuals with obesity - Exclusion Criteria:
Individuals without obesity (lean) - inclusion criteria
Individuals without obesity (lean) - exclusion criteria
From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.
From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.
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.
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.
Time frame: 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.
Time frame: Baseline
Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.
Time frame: Baseline
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
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.
Contact information is provided by the study sponsor or research team.
Kenneth Verboven
CONTACT
Lisa Mennens
CONTACT
+32 (0)499 / 72 29 93
Hasselt University
Other
The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.
Acronym: EVO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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