Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In Anorexia Nervosa (HOPE)
HOrmone Profiles and Energy Metabolism Signatures in Hypothalamic-like Neurons Generated From Patients With Anorexia Nervosa
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maria Consolata Miletta, PhD
- Phone Number: +41(0)432533105
- Email: maria.miletta@uzh.ch
Study Locations
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Zurich, Switzerland, 8006
- Recruiting
- Private Praxis, Prof. Dr. Med. Gabriella Milos
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Contact:
- Grabriella Milos, Dr. med.
- Phone Number: +41(0)432533105
- Email: maria.miletta@uzh.ch
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Contact:
- Gabriella Milos, Dr. med.
- Email: gabriella.milos@usz.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control-Healthy Patients
Healthy women
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AN-patients
Patients suffering from enduring Anorexia Nervosa
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in NPY and α-MSH secretion after hormone exposure in patient-derived hypothalamic-like neurons
Time Frame: Baseline (0 minutes) and at predefined time points up to 24 hours after exposure
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NPY and α-MSH levels will be measured in the culture medium of hypothalamic-like neurons derived from participants with anorexia nervosa and healthy controls.
Results will be reported as concentrations in ng/mL and/or fold change from baseline after exposure to metabolic hormones.
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Baseline (0 minutes) and at predefined time points up to 24 hours after exposure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Consolata Miletta, PhD, University of Zurich
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-02426
- Nr. CRSK-3_237487 / 1 (Other Grant/Funding Number: Swiss National Science Foundation- SPARK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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