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

Launched by UNIVERSITY OF COLORADO, BOULDER · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how a specific type of tiny particles, called adipocyte-derived extracellular vesicles (Ad-EVs), relate to weight loss and blood vessel health in adults with obesity. Researchers believe that higher levels of these particles in the blood may be linked to poorer blood flow and that losing weight may help lower these levels, potentially improving blood vessel function. The trial aims to see if reducing Ad-EVs through intentional weight loss can lead to better blood vessel health, which is important for preventing heart disease and other health issues.

To participate in the trial, you need to be at least 40 years old and have a body mass index (BMI) greater than 25, which indicates obesity. However, if your BMI is below 25, you may still be eligible for the first part of the study. Some individuals may not qualify, such as those with certain medical conditions or who smoke regularly. If you join the trial, you'll undergo tests to measure your Ad-EVs and blood vessel function, and you will receive guidance on weight loss. This research is a chance to help us understand how weight loss can benefit cardiovascular health in people with obesity.

Gender

ALL

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