[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642902":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":71,"collaborators":37,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":37,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":37,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":37,"overallStatus":45,"whyStopped":37,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The OFF Group","EXPERIMENTAL","This group of subjects will have their GES interrogated and observed as well as having the device turned off for the duration of the experiment. The device will then be re-interrogated and turned back on at the end of the experiment.",[13],"Device: Gastric Electrical Stimulator",{"label":15,"type":16,"description":17,"interventionNames":18},"SHAM Group","SHAM_COMPARATOR","This group of subjects will have their GES interrogated and observed yet will not have the device turned off for the duration of the experiment. The device will then be re-interrogated at the end of the experiment. This is to retain the illusion of the device being turned back on.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Gastric Electrical Stimulator","Device will either be turned off for the duration of the experiment, or the device will be left on for the duration of the experiment",[15,9],[26],"GES",[28],{"name":29,"affiliation":30,"role":31},"Thomas V Nowak, MD","IU School of Medicine\u002FIU Health","PRINCIPAL_INVESTIGATOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Maureen V Schilling, BA","CONTACT","3172782064",null,"maschi@iu.edu",{"name":29,"role":35,"phone":40,"phoneExt":37,"email":41},"3179484272","tvnowak@iu.edu",[43,63],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Indiana University Hospital","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-86.15804,39.76838,{"lat":55,"lon":54},[58,61,62],{"name":59,"role":35,"phone":60,"phoneExt":37,"email":38},"Maureen V Schilling, BS","317-278-2064",{"name":29,"role":35,"phone":40,"phoneExt":37,"email":41},{"name":29,"role":31,"phone":37,"phoneExt":37,"email":37},{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},{"type":52,"coordinates":65},[54,55],{"lat":55,"lon":54},[68,70],{"name":69,"role":35,"phone":60,"phoneExt":37,"email":38},"Maureen Schilling, BA",{"name":29,"role":35,"phone":40,"phoneExt":37,"email":41},{"type":31,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Thomas V. Nowak","Medical Doctor","100642902","effect-of-gastric-electrical-stimulation-on-serum-insulin-levels-100642902",false,"NCT07635576","Effect of Gastric Electrical Stimulation on Serum Insulin Levels","Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects","Inclusion Criteria:\n\n* • At least 18 years of age.\n\n  * Documented diagnosis of gastroparesis\n  * Not taking diabetic prescribed exogenous insulin.\n  * Patient has a GES device that has been implanted for at least 3 months.\n  * Willing to give up to 8 blood samples.\n  * Willing to lie in a bed for up to 5.5 hours.\n\nExclusion Criteria:\n\n* • Pregnancy\n\n  * History of allergic reaction to EKG lead placement adhesives.\n  * Unable to give informed consent.\n  * Unwilling to give up to 8 5 ml blood samples.\n  * Unwilling to lie in a bed for up to 5.5 hours.","ALL","18 Years","70 Years",{"count":85,"type":86},32,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this observational study is to determine how much effect turning the subject's Gastric Electrical Stimulator off for up to four hours will have on levels of insulin, C-peptide, GLP-1 and Glucose levels in patients with gastroparesis who have had a GES for at least three months, who are not taking diabetic prescribed exogenous insulin. EKG recordings will be made and analyzed for Heart Rate Variability and Power Spectral Analysis.",[92],"Gastroparesis Nondiabetic","2026-06-03",{"date":95,"type":96},"2026-06-09","ACTUAL",{"date":98,"type":86},"2026-06-08",{"date":100,"type":86},"2030-09-30",{"name":5,"class":6},2]