Small Extracellular Vesicles and Insulin Action
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-55
SponsorWashington University School of Medicine
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- People with Metabolically Unhealthy Obesity - Low Calorie Diet
Treatment groups
72 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov