Small Extracellular Vesicles and Insulin Action
Recruiting · NCT05933707 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
People with Metabolically Unhealthy Obesity - Low Calorie Diet
What this trial is about
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 take part
Age range
25 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States