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Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function

Adipocyte-Derived Extracellular Vesicles; Novel Biomarker and Mediator of Obesity-Related Endothelial Dysfunction

Who can join

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

Age
40 Years and older
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

Not stated in the study description — ask the study team about visits and procedures.

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 tiny particles released by fat cells and how they relate to blood vessels widening in adults with obesity. It also looks at whether weight loss lowers these particles and helps blood vessels widen. The study includes adults age 40 and older, with different body size requirements for each phase.

Changes in adipose tissue biology are now recognized as a key factor underlying the increased risk of metabolic and cardiovascular disease with obesity. Clinical interest in adipocyte-derived extracellular vesicles (Ad-EVs) has intensified due to their potential as circulating biomarkers of adipose tissue health and systemic messengers, regulators and mediators of cardiometabolic health and disease with obesity. The investigators hypothesize that elevated Ad-EVs in adults with obesity will be negatively associated with endothelium-dependent vasodilation. Furthermore, the investigators hypothesize that in adults with obesity, intentional weight loss-induced reduction in circulating Ad-EVs is associated with greater endothelium-dependent vasodilation.

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

Eligibility

Who can join

  • Age 40 or older.
  • Phase 1: BMI below 25 or above 25. BMI is a measure of body size based on height and weight.
  • Phase 2: BMI above 25.

Who can't join

  • Currently smoke, or have alcohol abuse or dependence as defined by the study.
  • Have a long-term medical condition, such as heart disease, a past heart attack or stroke, cancer, or diabetes.
  • Have blood pressure with a top number above 160 or a bottom number above 100.
  • Regularly do hard exercise, such as running, more than 3 times a week for more than 30 minutes each time.
  • Are pregnant, breastfeeding, or planning pregnancy in the next 4–6 months.
  • Have had anaphylaxis, a severe allergic reaction, to Betadine, lidocaine, or iodine.
  • Have Raynaud’s disease, which affects blood flow to fingers and toes, or a history of blood clotting problems.
  • Take blood thinners, medicines that affect clotting, or statins, which lower cholesterol.

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

Official eligibility criteria

Inclusion criteria: * Age ≥40 years * BMI \<25 kg/m2 and BMI \>25 kg/m2 for Phase 1 and BMI \>25 kg/m2 for Phase 2. Rationale for defining obesity as BMI \>25 kg/m2 Exclusion criteria: * Current smoker * Chronic overt medical condition (e.g., evidence of coronary artery disease on resting ECG, any history of myocardial infarction or stroke, or cancer, diabetes based on fasting blood glucose concentration) * Alcohol abuse or dependence defined as more than 14 standard drinks/week and no more than 4 standard drinks/day for men and 7 standard drinks/week and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wines, 1 ½ ounces of 80-proof distilled spirits) reported during the medical history/physical exam * Stage III hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg) * Regular vigorous aerobic/endurance exercise (\>3 bouts/week, \>30 minutes/bout at a workload \>6 METS) * Women who are pregnant or breastfeeding * History of anaphylaxis to betadine, lidocaine, iodine * Raynaud's disease * History of clotting disorders * Anyone taking blood thinners and clotting medications * Anyone taking statin medication * Planned pregnancy in coming 4-6 months

Study sites (1)

CO