Anorexia Nervosa and Its Effects on Brain Function, Body... | NCT05357053

Studies
Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction in Adolescents

NCT05357053

Sponsor

Turku University Hospital

Status

Active, not recruiting

Last Update Posted

Sep 22, 2025Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Anorexia Nervosa

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Mar 28, 2022

First Submission Date that Met QC Criteria

Apr 26, 2022

First Posted Date

May 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 22, 2025Actual

Name	Class
University of Turku	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the research project is to investigate the neurological, physiological and behavioral underpinnings associated with the development of anorexia nervosa in adolescents. The goal of the project is to enable new ways to both predict the course of the disease and to influence this process.

Detailed Description

The aim of the project is to enable new ways to both predict and influence the course of anorexia nervosa. This is a three-year follow-up study in which we investigate the neurological and physiological factors underpinnings of anorexia nervosa with structural and functional magnetic resonance imaging (fMRI). In addition to this, a variety of methods is used, such as physiological measurements and questionnaire data, as well as investigation of intestinal microbiota associated with anorexia nervosa. Altogether 100 girls aged 13-17 will be recruited for the study: 50 patients with anorexia nervosa and 50 healthy controls. The participants are monitored annually and the fMRI scan is repeated at the last visit. Additionally, 40 participants (20 patients and 20 healthy controls) will participate in a cardiac sub-study. In this, the participants will also have an MRI scan and ultrasound examination of the heart.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anorexia nervosa patients		Anorexia nervosa patients
Healthy normal weight controls		Healthy normal weight controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in brain reward system and metabolism in anorexia nervosa patients	Anorexia nervosa patients and controls are studied using fMRI imaging and followed up for 3 years. Reward system function is measured using fMRI and metabolism using blood oxygen level-dependent (BOLD) echo-planar imaging.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria for anorexia nervosa patients:

Female sex
Age 13-17 years
Body mass index < 17.5 kg/m2
Currently fulfilling modified Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis criteria for anorexia nervosa with or without amenorrhea
Anorexia nervosa diagnosed within 2 yers

Inclusion criteria for healthy controls:

Female sex
Age 13-17 years
Body mass index 18,5-25 kg/m2
No lifetime history of obesity (Body mass index ≥ 30) or eating disorders

Exclusion criteria:

Any chronic illness or medication that could affect glucose metabolism or neurotransmission
Any other current mental disorder (excluding anorexia nervosa for the patient participants)
Severe previous mental disorder (excluding anorexia nervosa for the patient participants)
Smoking of tobacco, snuffing, or use of narcotics
Abusive use of alcohol

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

The study population comprises 50 female adolescents with anorexia nervosa meeting the inclusion criteria. They are compared with 50 age and sex-matched healthy normal weight controls.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Max Karukivi, MD, PhD	Turku University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Turku PET Centre		Turku		20521	Finland

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa
D001068	Feeding and Eating Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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