NCT07580209 Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In Anorexia Nervosa
| NCT ID | NCT07580209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maria Miletta |
| Condition | Anorexia Nervosa |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2026-04-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The main questions it aims to answer are: Do 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. Participants will: Attend 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.
Eligibility Criteria
Inclusion Criteria: Female 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/m² or documented BMI ≤18.5 kg/m² within the past 12 months Ability to provide informed consent Sufficient proficiency in the study language (German) For healthy controls: Female participants aged 18-45 years BMI between 18.5 and 24.9 kg/m² No current or past diagnosis of eating disorders No major psychiatric disorder Ability to provide informed consent Exclusion Criteria: Pregnancy 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
Contact & Investigator
Maria Consolata Miletta, PhD
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT07580209 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07580209 currently recruiting?
Yes, NCT07580209 is actively recruiting participants. Contact the research team at maria.miletta@uzh.ch for enrollment information.
Where is the NCT07580209 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT07580209 clinical trial?
NCT07580209 is sponsored by Maria Miletta. The principal investigator is Maria Consolata Miletta, PhD at University of Zurich. The trial plans to enroll 10 participants.