[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postprandial-hypoglycemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postprandial-hypoglycemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":19},"100640765","phase-2-anakinra-for-the-treatment-of-postprandial-hypoglycemia-in-a-patient-with-total-gastrectomy-and-end-stage-renal-disease-100640765",false,"NCT07580079","Anakinra for the Treatment of Postprandial Hypoglycemia in a Patient With Total Gastrectomy and End-Stage Renal Disease","Anakinra for the Treatment of Recurrent Postprandial Hypoglycemia After Total Gastrectomy in a Patient With End-Stage Renal Disease","AnPHy-ReD","This is an N-of-1 Trial, tailored-designed to a single participant.\n\n* total gastrectomy\n* severe episodes of postprandial hypoglycaemia after total gastrectomy","MALE",{"count":19,"type":20},1,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Post-meal low blood sugar (postprandial hypoglycemia) is a common problem after certain stomach surgeries like gastric bypass or stomach removal. It usually happens 1 to 3 hours after eating and can cause symptoms such as tiredness, hunger, sweating, dizziness, trouble speaking, or even fainting. Right now, there is no approved medication for this condition-only a careful diet reduced in sugars and refined carbohydrates can sometimes help reduce symptoms.\n\nThe AnPHy-ReD study is a personalized research study, designed for just one patient. This patient is a 52-year-old man who has been struggling with severe post-meal low blood sugar ever since his stomach was removed due to tumor in 2017. He also has end-stage kidney disease and needs dialysis three times a week.\n\nThe study is being conducted at the Cantonal Hospital of Olten in Switzerland and lasts 10 weeks, including 24 study visits. Most of these visits will happen during the patient's regular dialysis sessions. For 6 weeks, the patient will take either the drug Anakinra or a placebo (a substance with no active ingredient), in a randomly chosen order. Neither the patient nor the doctors will know which one he is taking at any given time.\n\nDuring the study, the medical team will perform various tests, including physical check-ups and blood samples to look at sugar levels, various hormone levels and inflammation in the body. The patient will also wear a continuous glucose monitor (CGM) to track his blood sugar levels 24\u002F7. In addition, he will do several mixed meal tests-this means drinking a shake containing fats, proteins, and sugars during a study appointment to see in real time how his body processes food, with doctors measuring changes in blood sugar, hormone and inflammation markers over time. During the study duration any side effects or symptoms will be closely monitored.\n\nAt the end of the study, the team will compare the results between the times the patient took Anakinra and the times he took the placebo. This will help find out if Anakinra can reduce sharp drops in blood sugar after meals and improve his overall condition.",[26,27,28,29,30,31],"Postprandial Hypoglycemia","End-stage Renal Disease (ESRD)","Gastrectomy","Glucose Metabolism Disorders","Inflammation","Gastric Bypass Surgery",[26,33,34,35,36,30],"End-Stage Renal Disease","Anakinra","Gastric Bypass","IL-1 receptor antagonist","NOT_YET_RECRUITING","2026-05-05",{"date":40,"type":41},"2026-05-12","ACTUAL",{"date":43,"type":20},"2026-07",{"date":45,"type":20},"2026-12",{"name":47,"class":48},"Marc Donath","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100470111","phase-3-canakinumab-for-the-treatment-of-postprandial-hypoglycemia-100470111","NCT05401578","Canakinumab for the Treatment of Postprandial Hypoglycemia","Canakinumab for the Treatment of Postprandial Hypoglycemia - CanpHy Study","CanpHy","Inclusion Criteria:\n\n* Patients after bariatric surgery (i.e. sleeve gastrectomy, Roux-en-Y gastric bypass, omega-loop bypass, biliopancreatic diversion) with documented hypoglycemia, i. e. \\\u003C 3.0 mmol\u002Fl and at least 5 hypoglycemic episodes per week despite dietary modification\n* For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study\n* Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* Any type of diabetes mellitus according to ADA criteria\n* Intolerance to the study drug\n* Signs of current infection\n* Any use of immunosuppressive medication\n* Use of any drug therapy for postbariatric hypoglycemia apart from acarbose (all remaining drugs have to be discontinued four half-life times before screening phase)\n* Neutropenia (leukocyte count \\\u003C 1.5 × 109\u002FL or ANC \\\u003C 0.5 × 109\u002FL)\n* Anemia (hemoglobin \\\u003C 11 g\u002FdL for males, \\\u003C 10 g\u002FdL for females)\n* Clinically significant kidney or liver disease (creatinine \\> 1.5 mg\u002FdL, AST\u002FALT \\> 2 × ULN, alkaline phosphatase \\> 2 × ULN, or total bilirubin \\[tBili\\] \\> 1.5 × ULN)\n* Uncontrolled congestive heart failure\n* Uncontrolled malignant disease\n* Currently pregnant or breastfeeding\n* Known or suspected non-compliance, drug or alcohol abuse\n* Meeting the criteria for vulnerability (e.g. participants incapable of judgment or participants under tutelage)\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.\n* Participation in another clinical trial using investigational drugs in the last 30 days or planned participation in the next 60 days\n* Previous enrolment into the current study,\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons","ALL","18 Years","75 Years",{"count":61,"type":20},56,[63],"PHASE3","The primary objective of this randomized trial is to test whether a treatment with canakinumab is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.",[26],[67,36,68,69,70],"bariatric surgery","postbariatric hypoglycemia","canakinumab","quality of life","RECRUITING","2025-01-27",{"date":74,"type":41},"2025-01-29",{"date":76,"type":41},"2023-04-17",{"date":78,"type":20},"2026-05-31",{"name":80,"class":48},"University Hospital, Basel, Switzerland"]