Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT05933707

Conditions

Obesity

Insulin Resistance

Metabolically Healthy Obesity

Obesity, Metabolically Benign

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Interventions

People with Metabolically Unhealthy Obesity - Low Calorie Diet

Study Details

Brief 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.

Conditions

Obesity

Insulin Resistance

Metabolically Healthy Obesity

Obesity, Metabolically Benign

Study ID

NCT05933707

Start date

Jun 14, 2023

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Metabolically healthy lean - Baseline testing only

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.

no intervention: People with Metabolically Healthy Obesity - Baseline testing only

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.

experimental: People with Metabolically Unhealthy Obesity - Low Calorie Diet

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.

Interventions

People with Metabolically Unhealthy Obesity - Low Calorie Diet

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

Primary outcome measure

  • Effect of exosomes on insulin sensitivity in cultured cells [ Time Frame: Baseline only (cross-sectional comparison of metabolically healthy lean, and of people with metabolically healthy or metabolically unhealthy obesity). ]
  • Change in the effect of exosomes on insulin sensitivity [ Time Frame: Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity ]

Central Contacts and Locations

Central contacts

Kyle Timmons

3142731879nutritionresearch@wustl.edu

Beth Henk

3143628250bhenk@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Kyle Timmons

314-273-1879nutritionresearch@wustl.edu

Beth Henk

3143628250bhenk@wustl.edu

Principal Investigator:

Dmitri Samovski, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • Obesity
  • Weight Loss
  • Exosomes
  • Extracellular vesicles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-17.