[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639245":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":10,"responsibleParty":34,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":10,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"Pennington Biomedical Research Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Metabolic Flexibility",null,"Ten Males and females (18-80 y) with extreme obesity (BMI: ≥60 kg\u002Fm2) will complete one outpatient visit and one inpatient visit with 36 hours of metabolic chamber testing evaluate energy metabolism (expenditure and fat oxidation), metabolic flexibility (response to a high-fat test meal) using gold-standard assessments of energy metabolism, metabolic flexibility, and body composition.",[13],"Other: High-fat test meal",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"High-fat test meal","At Visit 2-D1, subjects will enter the chamber at approximately 17:30 and exit the following morning at 07:00. Energy expenditure, respiratory exchange ratio (RER), and 12-h oxidation of CHO, fat, and protein will be calculated per standard PBRC protocols. While in the chamber, participants will collect all their urine for measurement of urinary nitrogen. Subjects will be served one high-fat meal while they are in the chamber (40% of the daily energy requirements).",[9],[20],"metabolic flexibility",[22],{"name":23,"affiliation":5,"role":24},"Christian Rodriguez, PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","8062249114","christian.rodriguez@pbrc.edu",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Eric Ravussin, PhD","2257633186","eric.ravussin@pbrc.edu",{"type":24,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Christian Rodriguez","T32 NIH Postdoctoral Fellow, Clinical Sciences, Principal Investigator","100639245","evaluating-metabolic-health-in-individuals-with-extreme-obesity-100639245",false,"NCT07613255","Evaluating Metabolic Health in Individuals With Extreme Obesity","Evaluating Energy Metabolism and Metabolic Health in Individuals With Extreme Obesity","Inclusion Criteria:\n\n* Healthy male or female\n* Between 18 - 80 years of age\n* BMI ≥60 kg\u002Fm2\n* Willing to consume pre-prepared meals\n* Willing to comply with the study procedures.\n* Willing to have biospecimens and images stored for future use.\n\nExclusion Criteria:\n\n* Diabetic individuals with complications such as:\n\n  * Diabetic eye disease requiring laser treatment\n  * Diabetic nerve disease associated with foot ulcers or amputations\n  * Diabetic vascular disease associated with gangrene or amputation\n  * Diabetic kidney disease accompanied by a creatinine greater than 2.0 mg\u002FdL\n  * Individuals with prior gastrointestinal surgery except appendectomy or cholecystectomy\n* Individuals with untreated thyroid disease\n* Individuals with untreated or poorly controlled binge eating disorder, bulimia, substance abuse or dependence, mania, and psychosis.\n* Women who are pregnant, trying to become pregnant, or currently breastfeeding.\n* Individuals with major organ system failure like cirrhosis, hepatic insufficiency, portal hypertension, severe renal insufficiency or on dialysis, severe arterial insufficiency, dementia or the inability to give an informed consent.\n* Being unwilling to comply with the study procedures.\n* Not willing to have biospecimens and\u002For images stored for future research use.",true,"ALL","18 Years","80 Years",{"count":49,"type":50},10,"ESTIMATED","OBSERVATIONAL","This research will evaluate energy metabolism (expenditure and fat oxidation), metabolic flexibility (response to a high-fat test meal) in 10 individuals with a BMI ≥60 kgm2 using gold-standard assessments of energy metabolism, metabolic flexibility, and body composition. Males and females (18-80 y) with extreme obesity (BMI: ≥60 kg\u002Fm2) will be recruited from Baton Rouge, Louisiana. Exclusion criteria include major organ failure, uncontrolled endocrine disease, severe psychiatric illness, pregnancy, and inability to comply with study procedures. The total duration of participation for each individual is estimated at approximately 10 days. If qualified, participants (BMI≥60 kg\u002Fm2; n=10) will complete one outpatient visit and one inpatient visit with 36hr metabolic chamber testing.",[54],"BMI>40",[20,56,57,58],"metabolism","extreme obesity","body composition","NOT_YET_RECRUITING","2026-05-26",{"date":62,"type":63},"2026-05-29","ACTUAL",{"date":65,"type":50},"2026-07-01",{"date":67,"type":50},"2026-08-01",{"name":5,"class":6}]