Clinical trial NCT05357053: Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction in Adolescents
Official title: Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction in Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Metabolism
Functional Imaging
Eating disorders
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2022-05-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Changes in brain reward system and metabolism in anorexia nervosa patients
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET Centre
Study officials:
affiliation: Turku University Hospital
name: Max Karukivi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: