[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590294":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":29,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":11,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":11},{"fullName":5,"class":6},"French Society of Digestive Endoscopy","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group: Immediate G-POEM","EXPERIMENTAL",null,[13],"Procedure: Immediate G-POEM",{"label":15,"type":16,"description":11,"interventionNames":17},"Delayed G-POEM : Standard Treatment Followed by G-POEM at 3 Months","ACTIVE_COMPARATOR",[18],"Procedure: Delayed G-POEM",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Immediate G-POEM","Gastric POEM (G-POEM) performed under general anesthesia. A submucosal tunnel will be created along the greater curvature of the stomach to access the pyloric muscle under endoscopic vision. The pylorus will be incised at two locations with a dual myotomy between the 5 and 8 o'clock positions on the clock face",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Delayed G-POEM","Participants will receive standard medical treatment, including prokinetic agents, antiemetics (ondansetron 8 mg twice daily), nutritional support, and dietary counseling. Laxative treatments will be prescribed as needed. After three months, participants will undergo G-POEM as described above",[15],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Antoine DEBOURDEAU","Medical doctor","100590294","g-poem-for-glycemic-control-in-diabetic-gastroparesis-100590294",false,"NCT06965543","G-POEM for Glycemic Control in Diabetic Gastroparesis","Randomized Controlled Clinical Trial Evaluating the Effect of Endoscopic Pyloromyotomy Via Gastric POEM on Glycemic Control in Patients With Diabetes and Gastroparesis","DIAPOEM","Inclusion Criteria:\n\n* Aged 18 to 90 years;\n* Diagnosed with diabetes for at least 5 years and be treated with optimized insulin therapy;\n* Severe gastroparesis with gastric retention \\>20% at 4h (confirmed by scintigraphy);\n* Failure of conventional gastroparesis treatment;\n* Continuous glucose monitoring (CGM) in use or willingness to use during study\n* Time in range (70-180 mg\u002FdL) \\\u003C70%\n\nExclusion Criteria:\n\n* Are treated with an automated insulin therapy system (closed-loop);\n* Have previously undergone gastric neurostimulation therapy with Enterra (Medtronic ©);\n* Have been treated with erythromycin in the past three months;\n* Do not provide informed consent;\n* Are pregnant or breastfeeding during the study period;\n* Are under legal guardianship;\n* Have contraindications to the POEM procedure, including contraindications to anesthesia and\u002For active anticoagulation that cannot be paused;\n* Have severe chronic constipation, defined by a Cleveland score \\>15 (Agachan et al., Dis Colon Rectum, 1996);\n* Have a history of esophagogastric surgery (excluding anti-reflux surgery), including esophagogastric resection or any type of bariatric surgery;\n* Have chronic intestinal pseudo-obstruction;\n* Have a clinical suspicion of chronic mesenteric ischemia, indicated by severe malnutrition, postprandial pain, and signs of digestive atherosclerosis;\n* Refuse to share CGM data via the Libre Link platform;\n* Plan or undergo changes in antidiabetic therapy or insulin delivery systems during the study period;\n* Are being treated with any gastric-emptying delaying agents, including GLP-1 receptor agonists;\n* Are undergoing treatment with ascorbic acid during the study;\n* Have not previously attempted therapy with at least one prokinetic drug;\n* Are actively treated with opioids;\n* Have had prior pyloromyotomy or pyloroplasty;\n* Have known eosinophilic gastroenteritis;\n* Have an organic obstruction of the pylorus or intestinal tract (e.g., fibrotic stenosis);\n* Have a severe coagulopathy;\n* Have esophageal or gastric varices and\u002For portal hypertension gastropathy;\n* Have decompensated liver cirrhosis (Child B or Child C);\n* Have an active gastroduodenal ulcer;\n* Have active cancer or precancerous conditions of the stomach or duodenum (dysplasia, gastric cancer, GIST).\n* Have a known medical condition that, in the investigator's opinion, could interfere with the study protocol;\n* Have experienced diabetic ketoacidosis requiring hospitalization within six months prior to enrollment;\n* Have had a severe hypoglycemic episode requiring hospitalization within six months prior to enrollment.","ALL","18 Years","90 Years",{"count":45,"type":46},40,"ESTIMATED","INTERVENTIONAL",[49],"NA","Gastroparesis, commonly caused by diabetes, affects 30-50% of diabetic individuals and complicates glycemic control due to its bidirectional relationship with blood glucose levels. Current treatments are often ineffective. G-POEM, a minimally invasive endoscopic technique, has demonstrated promising results in improving digestive symptoms, particularly in diabetic patients, with over 80% success. However, its impact on glycemic control has not yet been investigated, highlighting the need for further research.",[52],"Gastroparesis",[54,52,55],"G-POEM (Gastric Per Oral Endoscopic Myotomy)","diabetic gastroparesis","NOT_YET_RECRUITING","2025-05-02",{"date":59,"type":60},"2025-05-11","ACTUAL",{"date":62,"type":46},"2025-07",{"date":64,"type":46},"2028-07",{"name":5,"class":6}]