Examining differences in fat-derived extracellular vesicles in obese individuals.
The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.
Hasselt University · NCT06444646
This study looks at how tiny particles from fat cells in people with obesity differ from those in lean individuals to see how these differences might affect health issues like insulin sensitivity and heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hasselt University (other) |
| Locations | 1 site (Genk, Limburg) |
| Trial ID | NCT06444646 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the differences in extracellular vesicles (EVs) derived from adipose tissue in individuals with obesity compared to lean individuals. It focuses on how these differences may relate to factors such as sex, insulin sensitivity, and the function of the blood-brain barrier. The study involves adipose tissue biopsies, blood sampling, and patient phenotyping to analyze the EV profiles from fat and immune cells. By understanding these differences, the research aims to shed light on the mechanisms linking obesity to related metabolic and cardiovascular diseases.
Who should consider this trial
Good fit: Ideal candidates include Caucasian adults with obesity (BMI ≥ 35 kg/m²) scheduled for bariatric surgery, as well as lean Caucasian females (BMI 18-24.9 kg/m²) scheduled for abdominal surgery.
Not a fit: Patients with cardiovascular, lung, kidney, brain, or malignant diseases, as well as those who smoke or abuse drugs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of obesity's role in metabolic diseases and lead to improved treatment strategies.
How similar studies have performed: While the specific focus on EVs from adipose tissue in this context may be novel, similar studies have shown promising results in understanding obesity-related mechanisms.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Genk, Limburg
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (RECRUITING)
Study contacts
- Study coordinator: Lisa Mennens
- Email: lisa.mennens@uhasselt.be
- Phone: +32 (0)499 / 72 29 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity