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Small Extracellular Vesicles and Insulin Action

Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 55 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators will isolate sEVs from subcutaneous abdominal adipose tissue biopsies and blood samples obtained from human participants with MHO, MUO or who are metabolically healthy and lean (MHL) and examine the effects of these sEVs on insulin resistance in muscle, liver and fat cells in culture and on multi-organ insulin sensitivity in lean and obese mice."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at why some people with obesity develop type 2 diabetes or heart and blood vessel disease, while others do not. It tests how tiny particles released by cells, called exosomes, from participants affect how cells grown in a lab and mice use energy. It is for people who are lean with healthy test results and people with obesity with either healthy or unhealthy test results.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Lean participants must have a BMI of 18.5–24.9. Participants with obesity must have a BMI of 30–50. BMI is a measure based on height and weight.
  • Lean participants and participants with obesity in the healthy group must have liver fat of 5% or less.
  • Those in the healthy group must have blood sugar below 100 mg/dL after fasting and below 140 mg/dL two hours after a sugar drink.
  • Those in the healthy group must have HbA1c of 5.6% or less and HOMA-IR below 2.5. HbA1c measures average blood sugar. HOMA-IR measures how well the body responds to insulin.
  • Participants with obesity in the unhealthy group must have liver fat of at least 5.6% and HOMA-IR of at least 2.5.
  • Those in the unhealthy group must also have at least one of these: HbA1c of 5.7%–6.4%, fasting blood sugar of at least 100 mg/dL, or blood sugar of at least 140 mg/dL two hours after a sugar drink.

Who can't join

  • A history of diabetes, serious diseases, or liver disease other than nonalcoholic fatty liver disease (fat buildup in the liver not caused by alcohol).
  • Drinking more than 21 units of alcohol per week for men or more than 14 units per week for women.
  • Taking medicines that could affect the study results.
  • Doing regular exercise for more than 120 minutes per week.
  • Being pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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