RecruitingNot ApplicableNCT05933707

Small Extracellular Vesicles and Insulin Action

Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action

Sponsor

Washington University School of Medicine

Enrollment

72 participants

Start Date

Jun 8, 2023

Study Type

INTERVENTIONAL

Conditions

Obesity Insulin Resistance Metabolically Healthy Obesity Obesity, Metabolically Benign

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

Min Age: 25 YearsMax Age: 55 Years

Inclusion Criteria3

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 Criteria4

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

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