NCT06776081Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Adipocyte-Derived Extracellular Vesicles; Novel Biomarker and Mediator of Obesity-Related Endothelial Dysfunction
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 1 Jul 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of Colorado, Boulder
- Diseases
- Obesity
- NCT number
- NCT06776081
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Jul 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anyone taking blood thinners and clotting medications
- Anyone taking statin medication
Other illness
- Stage III hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg)
- History of anaphylaxis to betadine, lidocaine, iodine
- Raynaud's disease
- History of clotting disorders
Lab values
- 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)
Other
- Current smoker
- 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
- Regular vigorous aerobic/endurance exercise (\>3 bouts/week, \>30 minutes/bout at a workload \>6 METS)
- Women who are pregnant or breastfeeding
- Planned pregnancy in coming 4-6 months
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Boulder Clinical and Translational Research Center (CTRC) Coordinator of this site? Confirm its status | Boulder | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.