[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Maria Miletta\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100637421","hormonal-and-metabolic-signatures-in-human-hypothalamic-neurons-in-anorexia-nervosa-100637421",false,"NCT07580209","Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In Anorexia Nervosa","HOrmone Profiles and Energy Metabolism Signatures in Hypothalamic-like Neurons Generated From Patients With Anorexia Nervosa","HOPE","Inclusion Criteria:\n\nFemale participants aged 18-45 years (premenopausal) Diagnosis of severe and enduring anorexia nervosa (illness duration ≥7 years, with documented functional impairment and non-response to appropriate treatments) Current BMI ≤18.5 kg\u002Fm² or documented BMI ≤18.5 kg\u002Fm² within the past 12 months Ability to provide informed consent Sufficient proficiency in the study language (German)\n\nFor healthy controls:\n\nFemale participants aged 18-45 years BMI between 18.5 and 24.9 kg\u002Fm² No current or past diagnosis of eating disorders No major psychiatric disorder Ability to provide informed consent\n\nExclusion Criteria:\n\nPregnancy or breastfeeding Severe medical comorbidities affecting metabolic or central nervous system function (e.g., uncontrolled endocrine, hepatic, renal, or cardiovascular diseases) Current psychosis or acute suicidality Current serious non-suicidal self-injury Substance dependence Use of medications that substantially alter metabolic or endocrine function (including high-dose systemic corticosteroids, hormonal contraceptives, or psychotropic medications such as antidepressants, antipsychotics, mood stabilizers, or anxiolytics) Positive status for HIV, hepatitis B (HBV), or hepatitis C (HCV) Intellectual disability impairing the ability to provide informed consent Insufficient proficiency in the study language",true,"FEMALE","18 Years","45 Years",{"count":22,"type":23},10,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to investigate cellular mechanisms of neuroendocrine and metabolic signaling in adult women with anorexia nervosa (AN) compared to healthy controls. The primary purpose is to understand how hypothalamic-like neurons derived from patient samples respond to metabolic hormones and regulate energy homeostasis.\n\nThe main questions it aims to answer are:\n\nDo hypothalamic-like neurons derived from individuals with AN show altered responsiveness to key metabolic hormones compared to neurons derived from healthy controls? Are there differences in cellular metabolism, gene expression profiles, and neuronal activity that reflect disease-relevant neuroendocrine dysfunction? Researchers will compare patient-derived cellular models from individuals with AN to those generated from matched healthy control participants to determine whether differences in hormone responsiveness, metabolic function, and neuronal signaling can be identified.\n\nParticipants will:\n\nAttend a single study visit at a recruiting clinical site Provide a small peripheral blood sample Undergo basic clinical assessment and anthropometric measurements Collected samples will be coded at the recruiting sites and transferred to a central research laboratory, where they will be used to generate induced pluripotent stem cells (iPSCs) and differentiate them into hypothalamic-like neurons. All experimental analyses are conducted in vitro and do not involve any intervention or treatment administered to participants.",[27],"Anorexia Nervosa",[27,29,30,31],"Eating Disorders","Hypothalamus","Neuroendocrinology","RECRUITING","2026-05-05",{"date":35,"type":36},"2026-05-12","ACTUAL",{"date":38,"type":36},"2026-04-30",{"date":40,"type":23},"2028-12",{"name":42,"class":43},"Maria Miletta","OTHER",""]