[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07031297":3,"trial-entities:NCT07031297":85,"trial-summary:NCT07031297":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":59,"locations":61,"central_contacts":75,"overall_officials":81,"references":83,"see_also_links":84},"NCT07031297","24-007465","Upper Body Subcutaneous Exosome Release in Response to a Meal in Obesity","Upper Body Subcutaneous Adipose Tissue Outflow Response to a Meal","RECRUITING","2028-05","2026-07","2026-08-05","2026-05-05","Mayo Clinic","OTHER",false,"The purpose of this study is to understand the specific outflow and difference between normal weight and volunteers with obesity of upper body subcutaneous adipose tissue in response to a mixed meal challenge by site specific cannulation of the superior epigastric vein. We will characterize the exosome signatures in response to a meal and compare to the exosome signature of arterialized venous plasma samples.",null,[19],"Obesity",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},20,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIAGNOSTIC_TEST","Meal Study","Participants will consume a mixed meal drink (Ensure) equivalent to 40% of basil metabolic rate as calculated via Harris Benedict equation.\n\nFollowing consumption of the drink they will undergo a series of blood draws over the following 4 hours:\n\n* Plasma glucose will be measured according to a mixed meal test protocol every 10 minutes for the first hour and then every 15, then 30 minutes for the last 3 hours.\n* 1 ml plasma aliquots for exosome analysis and insulin concentrations will be drawn every 30 minutes following consumption of ensure for 4 hours.\n* Blood gasses will be drawn every 30 minutes for the 4 hours following the meal.\n\nParticipants will undergo a second abdominal adipose tissue biopsy 3 hours following mixed meal drink.",[34,35],"Normal weight group","Obesity group",[37],{"measure":38,"description":39,"timeFrame":40},"Adipose tissue blood flow","Blood flow will be measured in the upper body subcutaneous adipose tissue using Xenon washout and reported as blood flow in ml\u002Fmin\u002F100g adipose tissue.","4 hours",[42],{"measure":43,"description":44,"timeFrame":45},"Glucose","Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg\u002FdL, results reported in mg\u002FdL","Baseline, 4 hours","ALL","18 Years","55 Years",true,{"inclusion":51,"exclusion":52,"raw_text":58},[],[53,54,55,56,57],"Participants taking medications know to affect blood flow (statins, β-blockers) or fatty acid or adipose tissue metabolism (TZDs, high dose fish oil supplements)","Diabetes, history of cardiovascular disease","Allergy to lidocaine","Post-menopausal women","Pregnant","Inclusion Criteria:\n\n• All women must be premenopausal\n\nExclusion Criteria:\n\n* Participants taking medications know to affect blood flow (statins, β-blockers) or fatty acid or adipose tissue metabolism (TZDs, high dose fish oil supplements)\n* Diabetes, history of cardiovascular disease\n* Allergy to lidocaine\n* Post-menopausal women\n* Pregnant",[60],"ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":72},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[69],{"name":70,"role":71},"Kelli A Lytle","PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},44.02163,-92.4699,[76],{"name":77,"role":78,"phone":79,"email":80},"Kelli A. Lytle, Ph.D.","CONTACT","507-255-1488","lytle.kelli@mayo.edu",[82],{"name":77,"affiliation":13,"role":71},[],[],{"nct_id":4,"conditions":86,"biomarkers":87},[19],[],{"nct_id":4,"found":49,"summary":89,"prompt_version":99},{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an interventional study planning to enroll 20 participants to understand the body's response to a meal.","completed","Understanding Exosome Release in Obesity After a Meal","This study aims to understand how your body, specifically the fat tissue in your upper body, releases tiny particles called exosomes after you eat a meal. Researchers want to see if there are differences in this process between people with obesity and those with normal weight. You would consume a mixed meal drink (Ensure) and then have blood drawn over four hours. The main goal is to measure blood flow in your fat tissue after this meal. This study is for adults aged 18 to 55, including premenopausal women, who do not have diabetes or heart disease, and are not taking certain medications that affect blood flow or fat metabolism. The study plans to enroll 20 participants, but its current status is unclear.","Blood flow in fat tissue will be measured at 4 hours after the meal.",123,"You would consume a mixed meal drink and then have a series of blood draws over four hours.","Not stated in the trial record.",[],"v2"]