Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
NCT ID: NCT06776081
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2024-07-01
2027-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
Weight loss without pharmacotherapy
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.
Interventions
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Weight loss without pharmacotherapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
Yes
Sponsors
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University of Colorado, Boulder
OTHER
Responsible Party
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Christopher DeSouza
Professor of Distinction
Principal Investigators
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Christopher DeSouza, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder
Locations
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University of Colorado Boulder Clinical and Translational Research Center (CTRC)
Boulder, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24TPA1301309
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-0523
Identifier Type: -
Identifier Source: org_study_id
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