[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510997":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":62,"collaborators":12,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":12,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":45,"whyStopped":12,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,13,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Metabolically healthy lean - Baseline testing only","NO_INTERVENTION","Metabolically healthy lean - Lean individuals that have good glucose (sugar) control (defined as normal fasting glucose, glucose tolerance and hemoglobin A1c), normal insulin sensitivity (defined as Homeostatic Model Assessment of Insulin Resistance \\[HOMA-IR\\] \\\u003C2.5) and normal intrahepatic triglyceride (fat) levels.\n\nDietary intervention - None.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"People with Metabolically Healthy Obesity - Baseline testing only","People with Metabolically Healthy Obesity - Persons with obesity that have good glucose (sugar) control, normal insulin sensitivity and normal intrahepatic triglyceride (fat) levels.\n\nDietary intervention - None.",{"label":17,"type":18,"description":19,"interventionNames":20},"People with Metabolically Unhealthy Obesity - Low Calorie Diet","EXPERIMENTAL","People with Metabolically Unhealthy Obesity - Persons with obesity with plasma glucose and intrahepatic triglyceride (fat) levels higher than recommended in combination with insulin resistance (defined as HOMA-IR ≥2.5).\n\nDietary intervention - Low calorie diet.",[21],"Behavioral: People with Metabolically Unhealthy Obesity - Low Calorie Diet",[23],{"type":24,"name":17,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Consumption of a low-calorie diet with caloric intake reduced by \\~25% to achieve \\~10% weight loss in about 4 to 5 months.",[17],[28],"Dietary weight loss",[30],{"name":31,"affiliation":5,"role":32},"Dmitri Samovski, PhD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":12,"email":38},"Kyle Timmons","CONTACT","3142731879","nutritionresearch@wustl.edu",{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},"Beth Henk","3143628250","bhenk@wustl.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","St Louis","Missouri","63110","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-90.19789,38.62727,{"lat":55,"lon":54},[58,60,61],{"name":59,"role":36,"phone":37,"phoneExt":12,"email":38},"Johanna Sonnenschein",{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"name":31,"role":32,"phone":12,"phoneExt":12,"email":12},{"type":63,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100510997","small-extracellular-vesicles-and-insulin-action-100510997",false,"NCT05933707","Small Extracellular Vesicles and Insulin Action","Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action","SEV","Inclusion Criteria:\n\n* Metabolically healthy lean subjects must have a BMI ≥18.5 and ≤24.9 kg\u002Fm²; Subjects with obesity must have a BMI ≥30.0 and ≤50.0 kg\u002Fm²\n* Metabolically healthy lean and people with metabolically healthy obesity must have intrahepatic triglyceride (IHTG) content ≤5%; fasting plasma glucose concentration \\\u003C100 mg\u002Fdl, 2-hr oral glucose tolerance plasma glucose concentration \\\u003C140 mg\u002Fdl, hemoglobin A 1C (HbA1c) ≤5.6% and HOMA-IR \\\u003C2.5.\n* People with metabolically unhealthy obesity must have intrahepatic triglyceride (IHTG) content ≥5.6%; HOMA-IR ≥2.5, and HbA1c 5.7%-6.4%, or fasting plasma glucose concentration ≥100 mg\u002Fdl, or 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg\u002Fdl.\n\nExclusion Criteria:\n\n* History of diabetes, liver disease other than NAFLD or other serious diseases,\n* Consume excessive amounts of alcohol (\\>21 units\u002Fweek for men and \\>14 units\u002Fweek for women),\n* Take medications that could affect the study outcome measures, engage in regular exercise (\\>120 min\u002Fweek),\n* Are pregnant or lactating",true,"ALL","25 Years","55 Years",{"count":77,"type":78},72,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goals of this research study are to: 1) understand why some people with obesity are protected from developing conditions such as type 2 diabetes and cardiovascular disease while others are more likely to develop obesity-related conditions; 2) assess the effect of small extracellular vesicles (sEVs also called exosomes), obtained from human participants, on metabolic function in cultured cells and in mice.",[84,85,86,87],"Obesity","Insulin Resistance","Metabolically Healthy Obesity","Obesity, Metabolically Benign",[84,89,90,91],"Weight Loss","Exosomes","Extracellular vesicles","2025-07-14",{"date":94,"type":95},"2025-07-17","ACTUAL",{"date":97,"type":95},"2023-06-08",{"date":99,"type":78},"2029-09-01",{"name":5,"class":6},1]