Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity.

Официальное название

The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Adipose tissue biopsy
  From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.
• Другое Blood sampling
  From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.
• Другое 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.
• Другое 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.

Первичные конечные точки

• General characterization of adipocyte- or adipose tissue-derived extracellular vesicles [Срок оценки: Baseline]
• General characterization of adipose tissue- and blood immune cells [Срок оценки: Baseline]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бельгия · 1 центр

• Ziekenhuis Oost-Limburg — Genk

Идентификаторы

NCT: NCT06444646 · CTU Z-2022041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗