[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415939":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":49,"collaborators":53,"id":56,"slug":19,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":19,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":19,"enrollmentInfo":64,"targetDuration":19,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic Per-Oral Pyloromyotomy (POP)","EXPERIMENTAL","The study cohort will include 40 patients with a HbA1c \\>7.5% with medically refractory gastroparesis who are scheduled to undergo POP. Each patient will undergo two 10-day periods of CGM at an interval of approximately seven months, one month prior to the procedure and six months after. Symptoms and diabetes management improvement will be measured by the Gastroparesis Cardinal Symptom Index (GCSI) scores and the Diabetes Self-Management Questionnaire (DSMQ).",[13],"Procedure: Pyloromyotomy",[15],{"type":16,"name":17,"description":9,"armGroupLabels":18,"otherNames":19},"PROCEDURE","Pyloromyotomy",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Mathew Allemang, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Deanne Nash, RN","CONTACT","216-445-0953","nashd@ccf.org",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Cleveland Clinic Foundation","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-81.69541,41.4995,{"lat":43,"lon":42},[46],{"name":22,"role":27,"phone":47,"phoneExt":19,"email":48},"216 491-7861","ALLEMAM@ccf.org",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Matthew Allemang","Principal Investigator",[54],{"name":55,"class":6},"Society of American Gastrointestinal and Endoscopic Surgeons","100415939",false,"NCT04696159","Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes","Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus","Inclusion Criteria:\n\n1. Patients 18 years of age and older\n2. Patients with gastroparesis with an average HbA1c\\> 7.5% over the past 3 months\n3. Patient that have a diagnosis of gastroparesis established by documented delayed gastric emptying by either a wireless motility capsule study or a nuclear gastric emptying study, with no evidence of gastric obstruction.\n4. Patients are able to complete all study requirements\n\nExclusion Criteria:\n\n1. Patients \\\u003C18 years of age\n2. Patients with gastroparesis with an average HbA1c\\\u003C 7.5% over the past 3 months\n3. Patients unable or refuse to complete the study requirements\n4. Patients who are unable or refuse to wear a CGM sensor\n5. Patients with insulin pumps\n6. Patients who already use a CGM","ALL","18 Years",{"count":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"NA","This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.",[72,73,74],"Diabetes Mellitus","Gastroparesis With Diabetes Mellitus","Gastroparesis","2025-07-21",{"date":77,"type":78},"2025-07-24","ACTUAL",{"date":80,"type":78},"2023-01-04",{"date":82,"type":66},"2027-06",{"name":51,"class":6},1]