[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-bariatric-hypoglycemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-bariatric-hypoglycemia":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":17,"phases":4,"briefSummary":18,"conditions":19,"keywords":21,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":45,"locationsCount":48},"100639974","an-expanded-access-protocol-to-provide-avexitide-in-patients-with-post-bariatric-hypoglycemia-100639974",false,"NCT07582874","An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia","Patients in this EAP will be eligible in one of two categories (Category A and Category B) as defined below:\n\n* Category A: Individuals who have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.\n* Category B: Individuals who participated in previous avexitide clinical trials conducted in PBH following RYGB; or documented LUCIDITY participants who signed ICF and were eligible for LUCIDITY based on screening and run-in, but were unable to be randomized due to completion of recruitment.\n\nKey Inclusion Criteria:\n\nApplicable to all patients:\n\n* Male or female, at least 18 years of age; able to understand the purpose and risks of the program, and provides written informed consent to participate.\n* Not eligible for or otherwise able to obtain access to avexitide via a clinical trial, and does not have access to satisfactory, alternative treatment options.\n* If female, cannot be breastfeeding or lactating, and if of childbearing potential must agree to use a highly effective method of birth control during EAP participation. A negative urine pregnancy test is required at time of entry.\n* If male, must agree to use a highly effective method of birth control during EAP participation.\n\nFor Category A:\n\n* Have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.\n\nFor Category B:\n\n* Have clinical diagnosis of PBH, and underwent documented RYGB ≥ 12 months prior to EAP eligibility assessment.\n* Has body mass index (BMI) of up to 40 kg\u002Fm2.\n* Treating physician confirmation of either participation in previous avexitide clinical trials conducted in PBH following RYGB; or documented LUCIDITY participant who signed ICF and was eligible for LUCIDITY based on screening and run-in, but was unable to be randomized due to completion of recruitment.\n\nKey Exclusion Criteria:\n\nApplicable to all patients:\n\n* Use of GLP-1 receptor agonists, glucose-dependent insulinotropic polypeptide (GIP)\u002FGLP-1 receptor dual agonists, and other GLP-1 receptor agonist combination therapies.\n* Presence of any clinically relevant condition which, per the judgment of the treating physician, may preclude the patient from safe treatment.\n\nFor Category B:\n\n* Have received another investigational drug for any indication within 5 half-lives of that drug or have participated in another interventional clinical study within 30 days prior to entry visit.\n* History of upper GI surgery affecting RYGB anatomy or function, other than RYGB.\n* Any known or suspected allergy to the investigational medicinal product (avexitide) or any related product (e.g., exenatide).\n* Abnormal liver function defined as AST and\u002For ALT \\> 5 times the upper limit of the normal and\u002For bilirubin level \\>3 times the upper limit of the normal within 12 weeks from entry.\n* Renal impairment, defined as an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 within 12 weeks from entry.\n* History or presence of insulinoma or other cause of endogenous hyperinsulinism other than PBH.\n* Presence of acute or chronic pancreatitis, history of idiopathic acute pancreatitis, or pancreatic cancer.","ALL","18 Years","EXPANDED_ACCESS","The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program. The safety of avexitide and patient treatment experience will be monitored during this program.",[20],"Post-bariatric Hypoglycemia",[22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"AVX","avexitide","PBH","post-bariatric hypoglycemia","hypoglycemia post bariatric surgery","reactive hypoglycemia","hypoglycemia","low blood sugar","Roux-en-Y gastric bypass (RYGB)","Roux-en-Y gastric bypass","Roux-en-Y","RYGB","gastric bypass","LUCIDITY","PREVENT","exendin","exendin 9-39","exendin 939","AVAILABLE","2026-05-05",{"date":43,"type":44},"2026-05-13","ACTUAL",{"name":46,"class":47},"Amylyx Pharmaceuticals Inc.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":48},"100626828","continuous-glucose-monitoring-with-ican-i3-in-post-bariatric-patients-with-late-dumping-syndrome-100626828","NCT07440706","Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome","A Prospective Randomized Study Evaluating the Efficacy and Safety of the iCan i3 Continuous Glucose Monitoring System in Post-Bariatric Patients With Late Dumping Syndrome","iCan3 Dumping","Inclusion Criteria:\n\n* Age 18-65 years\n* History of Roux-en-Y gastric bypass ≥12 months\n* Clinical diagnosis of late dumping syndrome\n* Stable body weight (\\\u003C5% variation in last 3 months)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Diagnosis of diabetes mellitus under treatment\n* Use of antidiabetic medications (except acarbose)\n* Pregnancy or breastfeeding\n* Cognitive impairment affecting study participation\n* Known hypersensitivity to CGM adhesives\n* Conditions increasing risk of hypoglycemia (e.g., prolonged fasting)\n* Active or prior malignancy\n* Need for imaging procedures during study period","65 Years",{"count":59,"type":60},60,"ESTIMATED","INTERVENTIONAL",[63],"NA","Late dumping syndrome is a common complication following Roux-en-Y gastric bypass, characterized by postprandial hypoglycemia with significant impact on patient safety and quality of life. Traditional capillary glucose monitoring has limited ability to detect rapid glycemic fluctuations.\n\nThis prospective randomized study aims to evaluate the efficacy and safety of the iCan i3 continuous glucose monitoring (CGM) system compared to conventional capillary glucose monitoring in detecting hypoglycemic events in post-bariatric patients with late dumping syndrome.\n\nParticipants will be randomized into two groups: one using CGM and one using standard fingerstick monitoring, and followed for 60 days. Clinical outcomes, hypoglycemia frequency, symptom correlation, and quality of life will be assessed.",[66,20],"Dumping Syndrome",[68,69,70,71,72],"Late Dumping Syndrome","Post-Bariatric Hypoglycemia","Continuous Glucose Monitoring","Roux-en-Y Gastric Bypass","Hypoglycemia","RECRUITING","2026-02-23",{"date":76,"type":44},"2026-02-27",{"date":78,"type":44},"2025-10-15",{"date":80,"type":60},"2026-12-31",{"name":82,"class":83},"Kaiser Clinic and Hospital","OTHER",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":61,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":48},"100409750","role-of-nutrient-transit-in-hyperinsulinemic-hypoglycemia-100409750","NCT04615546","Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia","Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia","Inclusion Criteria:\n\n* Male or female patients 18-70 years of age\n* Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)\n* Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)\n\nExclusion Criteria:\n\n* Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.\n* Participation in any clinical investigation within 4 weeks prior to dosing\n* History of or current insulinoma\n* Active infection or significant acute illness within 2 weeks prior to dosing\n* Female patients who are pregnant or lactating\n* Women of childbearing potential and not utilizing effective contraceptive methods\n* Inadequate end organ function as defined by: Serum creatinine \\>2.0 mg\u002FdL, alanine transaminase (ALT) and aspartate aminotransferase (AST) \\> 2 x Upper Normal Limit\n* Allergy to test meal or medications used in the study",true,{"count":59,"type":60},[63],"Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.",[69],"2024-12-02",{"date":98,"type":44},"2024-12-04",{"date":100,"type":44},"2020-05-06",{"date":102,"type":60},"2026-06",{"name":104,"class":83},"Stanford University","Post Bariatric Hypoglycemia"]