Small Extracellular Vesicles and Insulin Action Study

This study is looking into why some people with obesity stay healthy while others develop conditions like type 2 diabetes. Researchers are studying small extracellular vesicles (sEVs, also called exosomes), which are tiny particles released by cells. They want to see how sEVs from people with different metabolic health (metabolically healthy lean, metabolically healthy obesity, and metabolically unhealthy obesity) affect how cells use insulin. If you have metabolically unhealthy obesity, you might be asked to follow a low-calorie diet to lose about 10% of your weight over 4 to 5 months. The main goal is to understand how sEVs impact insulin sensitivity. This study is looking for 72 participants between 25 and 55 years old. Eligibility includes specific BMI ranges and certain blood sugar and liver fat levels.

Study design: This is an interventional study planning to enroll 72 participants. It compares different groups of people and involves a low-calorie diet for some participants.
What's involved: If you have metabolically unhealthy obesity, you would follow a low-calorie diet for about 4 to 5 months. Blood samples and adipose tissue biopsies will be taken.
Compensation: Not stated in the trial record.
Follow-up: Insulin sensitivity will be measured at baseline and again after about 4-5 months for those on the diet.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Small Extracellular Vesicles and Insulin Action

Recruiting

NAAges 25–55InterventionalBasic science

Washington University School of Medicine

~72 participants

Updated 2026-07-17 on ClinicalTrials.gov

What's tested:People with Metabolically Unhealthy Obesity - Low Calorie Diet

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Effect of exosomes on insulin sensitivity in cultured cells

Measured over Baseline only (cross-sectional comparison of metabolically healthy lean, and of people with metabolically healthy or metabolically unhealthy obesity).

+1 more outcome measured

Conditions

Obesity

Insulin Resistance

Metabolically Healthy Obesity

Obesity, Metabolically Benign

Where it's being run

1 sites across 1 states

Missouri1

Study leadership

Dmitri Samovski, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Kyle Timmons

[email protected]

3142731879

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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.

Trialytics