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

Part of paid clinical trials in Boulder, Colorado.

Sponsor
University of Colorado, Boulder
Study ID
NCT06776081
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Weight loss without pharmacotherapy — OTHER
    Adults with obesity participating in the 12-week hypocaloric diet-induced weight loss intervention will be individually counseled by the Clinical and Translational Research Center (CTRC) bionutritionist to consume a hypocaloric diet consistent with current dietary recommendations for weight loss until a 6-10% weight loss is achieved.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: No Intervention: Phase 1
    Phase 1 is a cross-sectional study to compare whether circulating Ad-EVs are associated with obesity-related endothelial dysfunction in normal weight adults and adults with obesity.
  • Experimental: Experimental: Phase 2
    Phase 2 employs an intervention study design, to determine in adults with obesity, the effects of intentional weight loss (12-weeks) on circulating Ad-EVs and their effect on endothelium-dependent vasodilation.

Primary Outcome Measure

Phase 1: Circulating adipocyte-derived extracellular vesicles (Ad-EVs) [ Time Frame: Circulating Ad-EVs will measured during Phase 1 visit 2 which is ~2 weeks from their respective start date. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Boulder Clinical and Translational Research Center (CTRC)BoulderColorado80309
Jared Greiner, MS
[email protected]
303-735-3056

Find similar trials in Boulder, CO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Colorado Boulder Clinical and Translational Research Center (CTRC)· Boulder, CO

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