Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity. (NCT06444646) | Clinical Trial Compass
RecruitingNot Applicable
Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity.
Belgium150 participantsStarted 2023-02-20
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
General characterization of adipocyte- or adipose tissue-derived extracellular vesicles
Timeframe: Baseline
2
General characterization of adipose tissue- and blood immune cells