Patient-derived Stem Cell Models of Anorexia Nervosa

NCT06259500 | Active Not Recruiting

• 1 other identifier: 2019 00170
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Microglia function and transcriptomic profiling

  phagocytic and immune activation capacity and whole transcriptomic profiling, anorexia nervosa vs healthy controls

  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

  2026

Study Arms (2)

anorexia nervosa

Other: observational

healthy controls

Other: observational

Interventions

observational OTHER

Profiling the function of iPSC derived Arcuate neurons and PBMC derived microglia

anorexia nervosa; healthy controls

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only female participants
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from specialised care unit Controls from community

You may qualify if:

• female
• years of age
• AN restrictive diagnosis as main diagnosis
• more than 5 years duration

You may not qualify if:

• female
• years of age
• BMI 18,5 - 25
• own or family member with eating disorder diagnosis
• own or family member with autism diagnosis

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: August 25, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)