RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adipocyte-Derived Extracellular Vesicles; Novel Biomarker and Mediator of Obesity-Related Endothelial Dysfunction

Quick Facts

Study Start:2024-07-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06776081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥40 years
  2. * 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
  1. * Current smoker
  2. * 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)
  3. * 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
  4. * Stage III hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg)
  5. * Regular vigorous aerobic/endurance exercise (\>3 bouts/week, \>30 minutes/bout at a workload \>6 METS)
  6. * Women who are pregnant or breastfeeding
  7. * History of anaphylaxis to betadine, lidocaine, iodine
  8. * Raynaud's disease
  9. * History of clotting disorders
  10. * Anyone taking blood thinners and clotting medications
  11. * Anyone taking statin medication
  12. * Planned pregnancy in coming 4-6 months

Contacts and Locations

Study Contact

Jared Greiner, MS
CONTACT
303-735-3605
greinerj@colorado.edu

Principal Investigator

Christopher DeSouza, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder

Study Locations (Sites)

University of Colorado Boulder Clinical and Translational Research Center (CTRC)
Boulder, Colorado, 80309
United States

Collaborators and Investigators

Sponsor: University of Colorado, Boulder

  • Christopher DeSouza, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Boulder

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Weight Loss

Additional Relevant MeSH Terms

  • Obesity
  • Weight Loss