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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Hasselt University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-20
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-06-05
• Last updated: 2025-09-15

Locations

1 site across 1 country: Belgium