Small Extracellular Vesicles and Insulin Action
The goals of this research study are to: 1) understand why some people with obesity are protected from developing conditions such as type 2 diabetes and cardiovascular disease while others are more likely to develop obesity-related conditions; 2) assess the effect of small extracellular vesicles (sEVs also called exoso
| Condition(s) | Obesity, Insulin Resistance, Metabolically Healthy Obesity, Obesity, Metabolically Benign |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goals of this research study are to: 1) understand why some people with obesity are protected from developing conditions such as type 2 diabetes and cardiovascular disease while others are more likely to develop obesity-related conditions; 2) assess the effect of small extracellular vesicles (sEVs also called exosomes), obtained from human participants, on metabolic function in cultured cells and in mice. |
| Who can participate | 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 |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Washington University School of Medicine |
| Locations | St Louis, Missouri, United States |
| Start date | 2023-06-08 |
| NCT ID | NCT05933707 |
| Official listing | https://clinicaltrials.gov/study/NCT05933707 |