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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07580209
Acronym
HOPE
Enrollment
10
Registered
2026-05-12
Start date
2026-04-30
Completion date
2028-12-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa, Eating Disorders, Hypothalamus, Neuroendocrinology

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.

Interventions

None listed

Sponsors

Maria Miletta
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in NPY and α-MSH secretion after hormone exposure in patient-derived hypothalamic-like neuronsBaseline (0 minutes) and at predefined time points up to 24 hours after exposureNPY 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.

Countries

Switzerland

Contacts

CONTACTMaria Consolata Miletta, PhD
maria.miletta@uzh.ch+41(0)432533105
PRINCIPAL_INVESTIGATORMaria Consolata Miletta, PhD

University of Zurich

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026