Effects of weight loss on fat-derived particles and blood vessel function
Adipocyte-Derived Extracellular Vesicles; Novel Biomarker and Mediator of Obesity-Related Endothelial Dysfunction
NA · University of Colorado, Boulder · NCT06776081
This study tests if losing weight can lower certain fat particles in the blood and improve blood vessel function in adults with obesity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Boulder (other) |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT06776081 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between adipocyte-derived extracellular vesicles (Ad-EVs) and endothelial function in adults with obesity. It aims to determine if higher levels of Ad-EVs are linked to poorer blood vessel function and whether intentional weight loss can reduce Ad-EVs, thereby improving vascular health. Participants will undergo a weight loss intervention without pharmacotherapy to assess these changes. The study focuses on understanding how fat tissue biology impacts cardiovascular health in obese individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a BMI greater than 25 kg/m2.
Not a fit: Patients with chronic medical conditions such as heart disease, diabetes, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into how weight loss improves cardiovascular health in obese patients.
How similar studies have performed: Other studies have shown promising results in understanding the role of adipocyte-derived factors in metabolic health, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boulder, Colorado
- University of Colorado Boulder Clinical and Translational Research Center (CTRC) — Boulder, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Christopher DeSouza, PhD — University of Colorado, Boulder
- Study coordinator: Jared Greiner, MS
- Email: greinerj@colorado.edu
- Phone: 303-735-3605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Weight Loss