Investigating the role of small extracellular vesicles in insulin action related to obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to understand the differences in metabolic health among individuals with obesity, focusing on those who are metabolically healthy versus those who are not. The study will isolate small extracellular vesicles (sEVs) from participants' blood and adipose tissue to assess their effects on insulin sensitivity in cultured cells and in mice. By examining the bioactive molecules carried by these vesicles, the researchers hope to uncover mechanisms that protect some individuals from obesity-related metabolic diseases. The findings could provide insights into potential therapeutic targets for improving insulin action in those with obesity.

Why it matters

Who can join: the full rules

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

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Dmitri Samovski, PhD — Washington University School of Medicine
• Study coordinator: Kyle Timmons
• Email: nutritionresearch@wustl.edu
• Phone: 3142731879

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lowering insulin to reduce liver fat production

  This study will try a short course of diazoxide to lower insulin and see if it reduces the liver's creation of new fat in adults with obesity, insulin resistance, and MASLD.

  Recruiting Phase 1 Columbia University · New York, New York · NCT07403604

• Electro-acupuncture for adults with obesity and insulin resistance

  This study will test whether electro-acupuncture can improve insulin resistance in adults with obesity.

  Recruiting Nanyang Technological University · Singapore · NCT06609200

• Investigating mitochondrial dysfunction in women with PCOS and infertility

  This study is trying to see if problems with energy production in cells are linked to polycystic ovary syndrome (PCOS) and infertility in women.

  Recruiting Semmelweis University · Budapest · NCT06167135

• Endoscopic sleeve gastroplasty for people with obesity and MASH

  This study will test whether endoscopic sleeve gastroplasty plus lifestyle changes helps adults with obesity and MASH lose weight and improve liver health compared with lifestyle changes alone.

  Recruiting at 2 sites Brigham and Women's Hospital · Boston, Massachusetts and 1 other locations · NCT06138821

• Impact of weight loss on fat tissue signaling in muscles

  This study is testing how losing weight affects fat tissue in muscles and whether it helps people with obesity improve their insulin sensitivity.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT06129110

• Timed-Restricted Eating for Improving Metabolic Health

  This study is testing whether changing when people with obesity and insulin resistance eat can improve their metabolic health, liver fat, brain function, inflammation, and sleep quality.

  Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam, North Holland · NCT06061042

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.