NCT05933707 Small Extracellular Vesicles and Insulin Action
| NCT ID | NCT05933707 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-06-14 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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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 72 participants in total. It began in 2023-06-14 with a primary completion date of 2028-06-01.
⚠ 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 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.
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
Contact & Investigator
Dmitri Samovski, PhD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT05933707 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 55 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 NCT05933707 currently recruiting?
Yes, NCT05933707 is actively recruiting participants. Contact the research team at nutritionresearch@wustl.edu for enrollment information.
Where is the NCT05933707 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05933707 clinical trial?
NCT05933707 is sponsored by Washington University School of Medicine. The principal investigator is Dmitri Samovski, PhD at Washington University School of Medicine. The trial plans to enroll 72 participants.
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