Taking people in United StatesNo phase

Studies whether fat-derived vesicles affect insulin action in obesity

Tests fat-derived tiny vesicles' effect on insulin in adults with obesity, aged 25 to 55.

Key facts

Who runs it: Washington University School of Medicine
Where: St Louis, United StatesSee the site
Trial code: NCT05933707
Registry title: Small Extracellular Vesicles and Insulin Action
Status: Recruiting
People taking part: 72 people, planned
Started: 14 Jun 2023
Expected to end: 31 Aug 2028
Type of study: Interventional, 3 groupsOne group gets no study treatment, for comparison.
Treatments tested: People with Metabolically Unhealthy Obesity - Low Calorie Diet
Record updated: 17 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are lean and metabolically healthy, or who have obesity that is either metabolically healthy or metabolically unhealthy.

Age: 25 Years to 55 Years
Sex: All sexes can join.
Disease stage: Three groups: lean and metabolically healthy (BMI ≥18.5 and ≤24.9 kg/m²), obesity with healthy metabolism, and obesity with unhealthy metabolism (BMI ≥30.0 and ≤50.0 kg/m²). The unhealthy group has liver fat (IHTG) ≥5.6% and HOMA-IR ≥2.5.
Earlier treatment: People cannot join if they take medications that could affect the study results.
Biomarker or test result: Healthy groups: liver fat (IHTG) ≤5%, fasting plasma glucose <100 mg/dl (5.6 mmol/L), 2-hr oral glucose tolerance glucose <140 mg/dl (7.8 mmol/L), HbA1c ≤5.6% (38 mmol/mol) and HOMA-IR <2.5. Unhealthy obesity group: HbA1c 5.7% (39 mmol/mol)-6.4% (46 mmol/mol), or fasting glucose ≥100 mg/dl (5.6 mmol/L), or 2-hr glucose ≥140 mg/dl (7.8 mmol/L).

Main reasons for not taking part

History of diabetes
Liver disease other than NAFLD or other serious diseases
Drinking more than 21 units of alcohol a week (men) or more than 14 units (women)
Taking medications that could affect the study results
Regular exercise of more than 120 min a week

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

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

Who cannot take part

Take medications that could affect the study outcome measures, engage in regular exercise (>120 min/week),
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),
Are pregnant or lactating

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 25 and 55 years old?

Where in United States

Washington University School of MedicineSt Louis, United StatesContact: Kyle TimmonsTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

Metabolically healthy lean - Baseline testing onlyNo study treatment, for comparison
Metabolically healthy lean - Lean individuals that have good glucose (sugar) control (defined as normal fasting glucose, glucose tolerance and hemoglobin A1c), normal insulin sensitivity (defined as Homeostatic Model Assessment of Insulin Resistance \[HOMA-IR\] \<2.5) and normal intrahepatic triglyceride (fat) levels. Dietary intervention - None.
People with Metabolically Healthy Obesity - Baseline testing onlyNo study treatment, for comparison
People with Metabolically Healthy Obesity - Persons with obesity that have good glucose (sugar) control, normal insulin sensitivity and normal intrahepatic triglyceride (fat) levels. Dietary intervention - None.
People with Metabolically Unhealthy Obesity - Low Calorie DietTreatment being tested
People with Metabolically Unhealthy Obesity - Persons with obesity with plasma glucose and intrahepatic triglyceride (fat) levels higher than recommended in combination with insulin resistance (defined as HOMA-IR ≥2.5). Dietary intervention - Low calorie diet.