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NCT Number: NCT07580209

Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Consolata Miletta, PhD

CONTACT

[email protected]

+41(0)432533105

Sponsors and collaborators

Lead sponsor

Maria Miletta

Other

Registry information

Official study title

HOrmone Profiles and Energy Metabolism Signatures in Hypothalamic-like Neurons Generated From Patients With Anorexia Nervosa

Acronym: HOPE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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