NCT05933707|RecruitingDMC
Small Extracellular Vesicles and Insulin Action
SEV
Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action
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SEV
Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action
Sponsor study identifier
interventional
72
1 country
1
Study Start
June 14, 2023
Actual (reported)Primary Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2023
Actual (reported)June 27, 2023
Actual (reported)July 6, 2023
Actual (reported)June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Effect of exosomes on insulin sensitivity in cultured cells
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.
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
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.
Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity
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 - 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 - 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.
Consumption of a low-calorie diet with caloric intake reduced by \~25% to achieve \~10% weight loss in about 4 to 5 months.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dmitri Samovski, PhD
Washington University School of Medicine
First Submitted
June 27, 2023
First Posted
July 6, 2023
Study Start
June 14, 2023
Actual (reported)Primary Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health
Differences in the content of microRNAs within exosomes obtained from plasma and adipose tissue
Baseline only (cross-sectional comparison of metabolically healthy lean, and of people with metabolically healthy or metabolically unhealthy obesity).
Differences in the content of lipids within exosomes obtained from plasma and adipose tissue
Baseline only (cross-sectional comparison of metabolically healthy lean, and of people with metabolically healthy or metabolically unhealthy obesity).
Changes in the content of microRNAs within exosomes obtained from plasma and adipose tissue
Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity
Changes in the content of lipids within exosomes obtained from plasma and adipose tissue
Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity
Insulin sensitivity
Baseline only (cross-sectional comparison of metabolically healthy lean, and people with metabolically healthy or metabolically unhealthy obesity).
Contact the study team to confirm eligibility.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 17, 2026
Record last verified: 2026-07
Currently there is no plan to share individual participant data.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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