Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In Anorexia Nervosa

NCT07580209 | Recruiting

• 2 other identifiers: 2025-02426Nr. CRSK-3_237487 / 1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa; Eating Disorders; Hypothalamus; Neuroendocrinology

Outcome Measures

Primary Outcomes (1)

• Change in NPY and α-MSH secretion after hormone exposure in patient-derived hypothalamic-like neurons

  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.

  Baseline (0 minutes) and at predefined time points up to 24 hours after exposure

Study Arms (2)

Control-Healthy Patients

Healthy women

AN-patients

Patients suffering from enduring Anorexia Nervosa

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from outpatient psychiatric practices specializing in eating disorders in Zurich, Switzerland. Individuals with anorexia nervosa will be identified by treating clinicians at participating sites, while healthy control participants will be recruited through the same clinical networks and local community outreach.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Miletta: lead

Study Sites (1)

Private Praxis, Prof. Dr. Med. Gabriella Milos

Zurich, 8006, Switzerland

RECRUITING

Related Publications (1)

• Treasure J, Zipfel S, Micali N, Wade T, Stice E, Claudino A, Schmidt U, Frank GK, Bulik CM, Wentz E. Anorexia nervosa. Nat Rev Dis Primers. 2015 Nov 26;1:15074. doi: 10.1038/nrdp.2015.74.

  PMID: 27189821 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Consolata Miletta, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Consolata Miletta, PhD

CONTACT

+41(0)432533105; maria.miletta@uzh.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 12, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)