NCT05199454 Role of Adiposomes in Endothelial Dysfunction
| NCT ID | NCT05199454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-16 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-05-16 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. The investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. Adiposomes are known to carry bioactive cargos such as proteins and micro RNAs; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. In the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in OB-T2D subjects. On top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (GSLs). These lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. Preliminary findings showed that in endothelial cells, GSL-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. Moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. Therefore, the central hypothesis is that adipose tissues in OB-T2D patients release GSL-loaded adiposomes that induce vascular endothelial dysfunction. The researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce GSL-loaded adiposomes, and subsequently alleviate vascular risk in OB-T2D patients. The investigators will test the hypotheses by pursuing the following aims: aim 1: Investigate the role of GSL-rich adiposomes in the pathogenesis of endothelial dysfunction in OB-T2D adults; aim 2: Test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: Examine changes in adiposome/caveolae axis following metabolic surgery and their association with vascular function.
Eligibility Criteria
Inclusion Criteria: * BMI ≥ 35 kg/m2 * Between ages 18-50 years * Not pregnant * Diabetic (Current use of diabetes medication or fasting glucose ≥126 mg/dL) * Medical clearance to participate in a moderate-intensity exercise program Exclusion Criteria: * Pregnant women * Current smokers * Currently abusing alcohol or drugs * Chronic heart, liver, or kidney diseases, autoimmune diseases, or cancer * Non-English speakers * History of allergic reactions to lidocaine
Contact & Investigator
Abeer M Mohamed, MD, PhD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT05199454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05199454 currently recruiting?
Yes, NCT05199454 is actively recruiting participants. Contact the research team at amahmo4@uic.edu for enrollment information.
Where is the NCT05199454 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05199454 clinical trial?
NCT05199454 is sponsored by University of Illinois at Chicago. The principal investigator is Abeer M Mohamed, MD, PhD at University of Illinois at Chicago. The trial plans to enroll 60 participants.
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