Anorexia NervosaHOPENCT07580209
Hormonal And Metabolic Signatures In Human Hypothalamic Neurons In Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Maria Miletta at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Private Praxis, Prof. Dr. Med. Gabriella Milos
Zurich, 8006
Grabriella Milos, Dr. med., +41(0)432533105, maria.miletta@uzh.ch
Gabriella Milos, Dr. med., gabriella.milos@usz.ch
About this study
Official title: HOrmone Profiles and Energy Metabolism Signatures in Hypothalamic-like Neurons Generated From Patients With 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:
Read more
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
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control-Healthy Patients | Healthy women | |
| AN-patients | Patients suffering from enduring Anorexia Nervosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0 minutes) and at predefined time points up to 24 hours after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Miletta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Miletta, University of Zurich
- Investigators
- Maria Consolata Miletta, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580209
- Sponsor's protocol ID
- 2025-02426
- Other IDs
- Nr. CRSK-3_237487 / 1, 2025
- Acronym
- HOPE
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the sensitive nature of the data and the small sample size, which may increase the risk of re-identification. Data use is restricted to the scope of the approved study protocol and informed consent, and access is limited to authorized study personnel.
Publications
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.
PubMed 27189821
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOrmone Profiles and Energy Metabolism Signatures in Hypothalamic-like Neurons Generated From Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT07580209
- Acronym / sponsor ID
- HOPE / 2025-02426
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Eating Disorders, Hypothalamus, Neuroendocrinology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maria MilettaUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Healthy Patients | – | –Healthy women |
| AN-patients | – | –Patients suffering from enduring Anorexia Nervosa |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 27189821Treasure 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the sensitive nature of the data and the small sample size, which may increase the risk of re-identification. Data use is restricted to the scope of the approved study protocol and informed consent, and access is limited to authorized study personnel.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Consolata Miletta, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Maria Miletta at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Consolata Miletta, PhD (+41(0)432533105, maria.miletta@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07580209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.