Clinical trial

Small Extracellular Vesicles and Insulin Action

Recruiting now · Not applicable · 1 countries · Registry ID NCT05933707

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 55 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Insulin Resistance, Metabolically Healthy Obesity, Obesity, Metabolically Benign

Full registry 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

Treatments and study arms

People with Metabolically Unhealthy Obesity - Low Calorie Diet

Behavioral

Consumption of a low-calorie diet with caloric intake reduced by \~25% to achieve \~10% weight loss in about 4 to 5 months.

Primary outcomes

Effect of exosomes on insulin sensitivity in cultured cellsBaseline only (cross-sectional comparison of metabolically healthy lean, and of people with metabolically healthy or metabolically unhealthy obesity).

Exosomes obtained from the plasma and adipose tissue of metabolically healthy lean participants, and participants with metabolically healthy or metabolically unhealthy obesity will be tested in cultured cells and mice to determine their effect on insulin sensitivity.

Change in the effect of exosomes on insulin sensitivityBefore and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity

Exosomes obtained from the plasma and adipose tissue of participants with metabolically unhealthy obesity before and after 10% weight loss will be tested in cultured cells and mice to determine their effect on insulin sensitivity.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Washington University School of Medicine🇺🇸 St Louis, Missouri, United States

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Kyle TimmonsContact

Email · Call 314-273-1879

Beth HenkContact

Email · Call 3143628250

Dmitri Samovski, PhDPrincipal Investigator