Investigating the role of small extracellular vesicles in insulin action related to obesity
Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action
This study is testing how tiny particles in the blood from people with obesity might affect insulin action to see why some people stay healthy despite being overweight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05933707 on ClinicalTrials.gov |
What this trial studies
This research aims to understand the differences in metabolic health among individuals with obesity, focusing on those who are metabolically healthy versus those who are not. The study will isolate small extracellular vesicles (sEVs) from participants' blood and adipose tissue to assess their effects on insulin sensitivity in cultured cells and in mice. By examining the bioactive molecules carried by these vesicles, the researchers hope to uncover mechanisms that protect some individuals from obesity-related metabolic diseases. The findings could provide insights into potential therapeutic targets for improving insulin action in those with obesity.
Who should consider this trial
Good fit: Ideal candidates include individuals with metabolically healthy obesity, metabolically unhealthy obesity, or metabolically healthy lean individuals.
Not a fit: Patients with a history of diabetes or serious liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for preventing or treating insulin resistance and related metabolic diseases in obese patients.
How similar studies have performed: While the specific approach of using sEVs in this context is novel, related studies have shown promise in understanding metabolic health and insulin resistance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Metabolically healthy lean subjects must have a BMI ≥18.5 and ≤24.9 kg/m²; Subjects with obesity must have a BMI ≥30.0 and ≤50.0 kg/m² * Metabolically healthy lean and people with metabolically healthy obesity must have intrahepatic triglyceride (IHTG) content ≤5%; fasting plasma glucose concentration \<100 mg/dl, 2-hr oral glucose tolerance plasma glucose concentration \<140 mg/dl, hemoglobin A 1C (HbA1c) ≤5.6% and HOMA-IR \<2.5. * People with metabolically unhealthy obesity must have intrahepatic triglyceride (IHTG) content ≥5.6%; HOMA-IR ≥2.5, and HbA1c 5.7%-6.4%, or fasting plasma glucose concentration ≥100 mg/dl, or 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg/dl. Exclusion Criteria: * History of diabetes, liver disease other than NAFLD or other serious diseases, * Consume excessive amounts of alcohol (\>21 units/week for men and \>14 units/week for women), * Take medications that could affect the study outcome measures, engage in regular exercise (\>120 min/week), * Are pregnant or lactating
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Dmitri Samovski, PhD — Washington University School of Medicine
- Study coordinator: Kyle Timmons
- Email: nutritionresearch@wustl.edu
- Phone: 3142731879
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.