Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT07580209

Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In Anorexia Nervosa

Led by Maria Miletta · Updated on 2026-05-12

10

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In Anorexia Nervosa

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18-45 years (premenopausal)
  • Diagnosis of severe and enduring anorexia nervosa lasting 7 years or more, with documented functional impairment and non-response to treatments
  • Current BMI 18.5 kg/m² or lower, or documented BMI 18.5 kg/m² or lower within the past 12 months
  • Ability to provide informed consent
  • Sufficient proficiency in German language
  • For healthy controls: female aged 18-45 years with BMI between 18.5 and 24.9 kg/m²
  • No current or past eating disorder diagnosis in healthy controls
  • No major psychiatric disorder in healthy controls
  • Ability to provide informed consent (healthy controls)
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Severe medical conditions affecting metabolism or central nervous system (e.g., uncontrolled endocrine, liver, kidney, cardiovascular diseases)
  • Current psychosis or acute suicidality
  • Current serious non-suicidal self-injury
  • Substance dependence
  • Use of medications that significantly alter metabolic or endocrine function, including high-dose corticosteroids, hormonal contraceptives, antidepressants, antipsychotics, mood stabilizers, or anxiolytics
  • Positive status for HIV, hepatitis B, or hepatitis C
  • Intellectual disability impairing ability to consent
  • Insufficient proficiency in German language

AI-Screening

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Trial Site Locations

Total: 1 location

1

Private Praxis, Prof. Dr. Med. Gabriella Milos

Zurich, Switzerland, 8006

Actively Recruiting

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Research Team

M

Maria Consolata Miletta, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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