Small Extracellular Vesicles and Insulin Action

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05933707
Status
Recruiting
Apply to this trial

Conditions

  • Insulin Resistance
  • Metabolically Healthy Obesity
  • Obesity
  • Obesity, Metabolically Benign

Eligibility Criteria

Sex
ALL
Age
25 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 8, 2023
Status verified
Jul 2025
Primary completion
Jan 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Johanna Sonnenschein
[email protected]
3142731879
Beth Henk
[email protected]
3143628250
Dmitri Samovski, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Washington University School of Medicine· St Louis, MO

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