[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marc Donath\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"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":63,"conditions":64,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100519723","phase-2-dapansutrile-in-diabetes-and-diabetes-related-complications---dapan-dia-100519723","NCT06047262","Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia","A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of the Oral NLRP3 Inhibitor Dapansutrile in Subjects With Type 2 Diabetes Mellitus","Dapan-Dia","Inclusion Criteria:\n\n* Diagnosis of type 2, Diabetes mellitus as defined by the criteria of the American Diabetes Association (ADA) Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (see Appendix 1) and recognized by the World Health Organization (WHO, 2019), for at least 3 months prior to the Baseline Visit\u002FDay 1\n* HbA1c value of ≥ 7.7% to ≤ 11.0% at the Screening Visit.\n* High-sensitivity C-reactive protein (hsCRP) ≥ 1.5 mg\u002FL at the Screening Visit.\n* Body mass index (BMI) ≥25 to ≤ 40 kg\u002Fm2 at the Screening Visit\n* Acceptable overall medical condition to safely participate in the study and complete all study procedures (particularly with regard to cardiovascular, renal, and hepatic conditions), in the opinion of the Investigator\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus\n* HbA1c value of ≤ 7.5% or ≥ 10.5% at the Baseline Visit\u002FDay 1, as determined at point of care (local laboratory)\n* Use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin\u002Finsulin analogues (as bolus or premixed insulin) within 12 weeks prior to the Screening Visit\n* Less than 80% compliance in taking investigational medicinal product by pill count during the Run-In Period, as assessed at the Baseline Visit\u002FDay 1\n* Significant weight loss (\\> 5 kg) in the 12 weeks prior to the Screening Visit\n* Systolic blood pressure (BP) ≥ 160 mmHg, diastolic BP ≥ 100 mmHg, or resting heart rate (HR) ≥ 100 beats\u002Fminute at the Screening Visit\n* Previous myocardial infarction, any cardiac surgery","ALL","18 Years","75 Years",{"count":61,"type":20},300,[23],"The aim of the study is to determine whether NLRP3 inhibition with dapansutrile represents a new pharmacological option for diabetes management with potential as an anti-inflammatory agent to also address micro- and macro-vascular risk and complications from diabetes.",[65],"Diabetes Mellitus, Type 2","RECRUITING","2026-02-23",{"date":69,"type":41},"2026-02-25",{"date":71,"type":41},"2024-07-09",{"date":73,"type":20},"2028-07-31",{"name":47,"class":48},6,""]