[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575730":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":12,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":12,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":12,"enrollmentInfo":65,"targetDuration":12,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":37,"whyStopped":12,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Colorado, Boulder","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"No Intervention: Phase 1","NO_INTERVENTION","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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental: Phase 2","EXPERIMENTAL","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.",[18],"Other: Weight loss without pharmacotherapy",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"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.",[14],[25],{"name":26,"affiliation":5,"role":27},"Christopher DeSouza, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},"Jared Greiner, MS","CONTACT","303-735-3605","greinerj@colorado.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Colorado Boulder Clinical and Translational Research Center (CTRC)","RECRUITING","Boulder","Colorado","80309","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-105.27055,40.01499,{"lat":47,"lon":46},[50],{"name":30,"role":31,"phone":51,"phoneExt":12,"email":33},"303-735-3056",{"type":27,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Christopher DeSouza","Professor of Distinction","100575730","adipocyte-derived-extracellular-vesicles-weight-loss-and-endothelial-function-100575730",false,"NCT06776081","Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function","Adipocyte-Derived Extracellular Vesicles; Novel Biomarker and Mediator of Obesity-Related Endothelial Dysfunction","Inclusion criteria:\n\n* Age ≥40 years\n* BMI \\\u003C25 kg\u002Fm2 and BMI \\>25 kg\u002Fm2 for Phase 1 and BMI \\>25 kg\u002Fm2 for Phase 2. Rationale for defining obesity as BMI \\>25 kg\u002Fm2\n\nExclusion criteria:\n\n* Current smoker\n* 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)\n* Alcohol abuse or dependence defined as more than 14 standard drinks\u002Fweek and no more than 4 standard drinks\u002Fday for men and 7 standard drinks\u002Fweek and 3 standard drinks\u002Fday 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\u002Fphysical exam\n* Stage III hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg)\n* Regular vigorous aerobic\u002Fendurance exercise (\\>3 bouts\u002Fweek, \\>30 minutes\u002Fbout at a workload \\>6 METS)\n* Women who are pregnant or breastfeeding\n* History of anaphylaxis to betadine, lidocaine, iodine\n* Raynaud's disease\n* History of clotting disorders\n* Anyone taking blood thinners and clotting medications\n* Anyone taking statin medication\n* Planned pregnancy in coming 4-6 months",true,"ALL","40 Years",{"count":66,"type":67},84,"ESTIMATED","INTERVENTIONAL",[70],"NA","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.\n\nThe 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.",[73,74],"Obesity","Weight Loss",[73,74],"2026-04-27",{"date":78,"type":79},"2026-04-28","ACTUAL",{"date":81,"type":79},"2024-07-01",{"date":83,"type":67},"2027-06-30",{"name":5,"class":6},1]