Small Extracellular Vesicles and Insulin Action

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jun 27, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring why some individuals with obesity do not develop related health problems, like type 2 diabetes and heart disease, while others do. The researchers are particularly interested in tiny particles called small extracellular vesicles (sEVs), which are produced by our cells. They will study how these particles affect metabolic functions using samples from human participants and experiments in mice.

To participate in this study, you need to meet certain criteria. If you are lean, your body mass index (BMI) should be between 18.5 and 24.9. If you have obesity, your BMI should be between 30 and 50. Participants should also have specific levels of liver fat and blood sugar. It's important to note that those with a history of diabetes or serious liver disease are not eligible, nor can those who drink excessively or are pregnant. If you join the study, you will help researchers learn more about the mechanisms behind obesity and its effects on health, which could lead to better treatments in the future.

Gender

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Eligibility 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