NCT06776081 Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
| NCT ID | NCT06776081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Boulder |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2024-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Christopher DeSouza, PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Boulder
Frequently Asked Questions
Who can join the NCT06776081 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06776081 currently recruiting?
Yes, NCT06776081 is actively recruiting participants. Contact the research team at greinerj@colorado.edu for enrollment information.
Where is the NCT06776081 trial being conducted?
This trial is being conducted at Boulder, United States.
Who is sponsoring the NCT06776081 clinical trial?
NCT06776081 is sponsored by University of Colorado, Boulder. The principal investigator is Christopher DeSouza, PhD at University of Colorado, Boulder. The trial plans to enroll 84 participants.
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