Actively Recruiting
Adipocyte-Derived Extracellular Vesicles as a Biomarker and Mediator of Endothelial Dysfunction Related to Obesity with Weight Loss Intervention
Led by University of Colorado, Boulder · Updated on 2026-04-28
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of adipocyte-derived extracellular vesicles (Ad-EVs) in adults with obesity, focusing on their connection to endothelial dysfunction and cardiovascular risks. The study aims to understand if higher levels of Ad-EVs relate to poorer blood vessel function and whether weight loss can reduce Ad-EVs and improve this function. This research is led by the University of Colorado, Boulder, and explores a novel biomarker linked to obesity-related vascular health. The study has two phases. Phase 1 is a cross-sectional comparison between adults of normal weight and those with obesity to assess the association between circulating Ad-EVs and blood vessel function. Phase 2 involves a 12-week weight loss intervention in adults with obesity, where participants follow a hypocaloric diet guided by a nutrition specialist to achieve 6-10% weight loss. Researchers will measure changes in Ad-EVs and blood flow responses before and after the intervention. Participants will attend visits where blood samples will be collected to measure circulating Ad-EVs, and forearm blood flow responses to specific agents will be assessed to evaluate endothelial function. These measurements occur approximately two weeks after starting Phase 1 and about 17 weeks after beginning Phase 2. The study monitors cardiovascular health markers and weight loss effects over time, with total participation lasting through the intervention and assessment periods.
CONDITIONS
Brief Title
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Body mass index (BMI) less than 25 kg/m2 for normal weight group in Phase 1
- Body mass index (BMI) greater than 25 kg/m2 for obese participants in Phase 1 and Phase 2
You will not qualify if you...
- Current smoker
- Presence of chronic medical conditions such as coronary artery disease, history of myocardial infarction or stroke, cancer, or diabetes
- Alcohol abuse or dependence exceeding specified daily or weekly limits
- Stage III hypertension with systolic blood pressure over 160 mmHg or diastolic over 100 mmHg
- Regular vigorous aerobic or endurance exercise more than 3 times per week for over 30 minutes at high intensity
- Women who are pregnant or breastfeeding
- History of severe allergic reactions to betadine, lidocaine, or iodine
- Diagnosis of Raynaud's disease
- History of clotting disorders
- Use of blood thinners or clotting medications
- Use of statin medications
- Planned pregnancy within the next 4 to 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants with obesity undergo a 12-week hypocaloric diet-induced weight loss intervention with individual counseling to achieve a 6-10% weight loss.
Regular counseling visits during the 12 weeks
Duration - Up to 17 weeks from start
Participants have assessments to measure circulating adipocyte-derived extracellular vesicles and forearm blood flow responses before and after the intervention.
2 visits (approximately at 2 weeks and 17 weeks from start)
Trial Site Locations
Total: 1 location
1
University of Colorado Boulder Clinical and Translational Research Center (CTRC)
Boulder, Colorado, United States, 80309
Actively Recruiting
Research Team
J
Jared Greiner, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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