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

Anorexia Nervosa Clinical Trial

— AVAIN_JR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357053
• Other study ID #: T163_2021
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Turku University Hospital
• Contact: Max Karukivi, MD, PhD
• Phone: 0503274340
• Email: max.karukivi[@]utu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Locations

Country	Name	City	State
Finland	Turku PET Centre	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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