Anorexia NervosaANSTEMNCT06259500
Patient-derived Stem Cell Models of Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Experimental and genetic data, as well as brain imaging, support a role of the hypothalamic Arcuate nucleus neurons and their communication with surrounding microglia in anorectic conditions, but it has until recently not been possible to explore these cells at a molecular level in anorexia nervosa (AN) patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- observational
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 25 Aug 2022to 31 Dec 2026
- 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
- Adult
Study population: Patients recruited from specialised care unit Controls from community
Who may be able to join
- female
- 18-45 years of age
- AN restrictive diagnosis as main diagnosis
- more than 5 years duration
- female
- 18-45 years of age
- BMI 18,5 - 25
Who cannot join
- -
- own or family member with eating disorder diagnosis
- own or family member with autism diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generation and Analysis of Patient-derived Stem Cell Models of Hypothalamic Neurons and Microglia in Anorexia Nervosa
Experimental and genetic data, as well as brain imaging, support a role of the hypothalamic Arcuate nucleus neurons and their communication with surrounding microglia in anorectic conditions, but it has until recently not been possible to explore these cells at a molecular level in anorexia nervosa (AN) patients. This attributed to the obvious lack of valid tissue and non-invasive imaging techniques of high enough resolution. Stem cell models have evolved as a useful tool for the exploration of other neuropsychiatric disorders with a comparably high genetic contribution as AN. The investigators will here use patient-derived induced pluripotent stem cells (iPSCs) to profile Arc neurons and peripheral blood mononuclear cell (PBMC) derived microglia in AN, thus defining molecules to explore as drug targets.
- Conditions
- Anorexia Nervosa
- Being tested
- observational
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
Profiling the function of iPSC derived Arcuate neurons and PBMC derived microglia
| Study group | Role | What they receive |
|---|---|---|
| anorexia nervosa | Not described Receives: Other: observational | |
| healthy controls | Not described Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microglia function and transcriptomic profiling
phagocytic and immune activation capacity and whole transcriptomic profiling, anorexia nervosa vs healthy controls
Measured: 2025
Arcuate neuron function and transcriptomic profiling
Electrical activity, transmitter release and whole transcriptomic profiling of iPSC derived Arcuate neurons, anorexia nervosa vs healthy controls
Measured: 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start25 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Ida AK Nilsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259500
- Sponsor's protocol ID
- 2019 00170
- Other IDs
- 2024-02508, 2019
- Acronym
- ANSTEM
- Status last verified
- Aug 2026
- First submitted
- 6 Feb 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation and Analysis of Patient-derived Stem Cell Models of Hypothalamic Neurons and Microglia in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06259500
- Acronym / sponsor ID
- ANSTEM / 2019 00170
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (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.
Experimental and genetic data, as well as brain imaging, support a role of the hypothalamic Arcuate nucleus neurons and their communication with surrounding microglia in anorectic conditions, but it has until recently not been possible to explore these cells at a molecular level in anorexia nervosa (AN) patients. This attributed to the obvious lack of valid tissue and non-invasive imaging techniques of high enough resolution. Stem cell models have evolved as a useful tool for the exploration of other neuropsychiatric disorders with a comparably high genetic contribution as AN. The investigators will here use patient-derived induced pluripotent stem cells (iPSCs) to profile Arc neurons and peripheral blood mononuclear cell (PBMC) derived microglia in AN, thus defining molecules to explore as drug targets.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anorexia nervosa | – | Other: observational |
| healthy controls | – | Other: observational |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients recruited from specialised care unit Controls from community
Key inclusion criteria (7 listed)
- female
- 18-45 years of age
- AN restrictive diagnosis as main diagnosis
- more than 5 years duration
- female
Key exclusion criteria (3 listed)
- -
- own or family member with eating disorder diagnosis
- own or family member with autism diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalProfiling the function of iPSC derived Arcuate neurons and PBMC derived microglia | Other | anorexia nervosa, healthy controls |
Primary outcome
Microglia function and transcriptomic profiling
Time frame: 2025
phagocytic and immune activation capacity and whole transcriptomic profiling, anorexia nervosa vs healthy controls
Arcuate neuron function and transcriptomic profiling
Time frame: 2026
Electrical activity, transmitter release and whole transcriptomic profiling of iPSC derived Arcuate neurons, anorexia nervosa vs healthy controls
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 6 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Karolinska Institutet at 1 site in Sweden.
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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microglia function and transcriptomic profiling (time frame: 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.