Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In Anorexia Nervosa

Sponsor
Maria Miletta
Study ID
NCT07580209
Status
Recruiting
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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
May 12, 2026
Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: Control-Healthy Patients
    Healthy women
  • Arm: AN-patients
    Patients suffering from enduring Anorexia Nervosa

Primary Outcome Measure

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 ]

Central Contacts

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