Anorexia Nervosa and Brain in Adolescence

April 18, 2024 updated by: Virve Kekkonen, Kuopio University Hospital
Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Anorexia nervosa is severe mental health problem with increased incidence rates in adolescence. Etiology of anorexia nervosa is still mostly unkonwn. Adolescence is also critical period of brain development.

Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in both acute and remission state of anorexia nervosa in adolescence.

Study group are young anorexia nervosa patients, and control group are healthy same-aged students.

Research methods include non-invasive brain imaging methods such as Transcranial Magnetic Stimulation (TMS), and Magnetic Resonance Imaging (MRI). Other research methods are assessment of body composition, laboratory tests, self-rated questionnaires and psychiatric interview.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Target study population is 50 participants. Study group (25 participants) are recruited from North Savo wellbeing services, Adolescent psychiatry outpatient clinic. Control group (25 participants) are recruited from Kuopio restrict lower and upper secondary schools.

Description

Inclusion Criteria:

Study group: 1) age 16-19 years, 2) BMI below 17.5, 3) diagnosis: anorexia nervosa or atypical anorexia nervosa 4) diagnosed within last two years. Inclusion criteria.

Control group : 1) age 16-19 years, 2) BMI over 19.0, 3) No lifetime obesity (BMI over 30) nor eating disorder.

Exclusion Criteria:

1) glucose metabolism disorder or any chronic medical disorder, or medicine with possible effects on neurotransmitters, 2) previous mental health problem (excluded anorexia nervosa or atypical anorexia nervosa in study group), 3) smoking, nicotine products, alcohol or any other substance abuse or dependence, 4) contraindication for used brain imaging method.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Adolescents diagnosed with anorexia nervosa or atypical anorexia nervosa.
Neuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups.
Control Group
Healthy adolescents.
Neuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuroimaging
Time Frame: Baseline and at 3 years' follow-up
Transcranial magnetic stimulation (TMS) combined with electroencephalogram (EEG)
Baseline and at 3 years' follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuroimaging
Time Frame: Baseline and at 3 years' follow-up
Magnetic resonance imaging (MRI)
Baseline and at 3 years' follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychiatric evaluation
Time Frame: Baseline and at 3 years' follow-up
Self-rated questionnaires measuring somatic and mentalh health (such as EDE-Q, BDI, substance use measurements) and structured psychiatric diagnostic interview (SCID)
Baseline and at 3 years' follow-up
Body composition measurement
Time Frame: Baseline and at 3 years' follow-up
InBody body composition measurement (non-invasive method to measure information about the quantity and segmentation of muscle, bone and fat tissue in body and about your basal metabolic rate)
Baseline and at 3 years' follow-up
Laboratory tests
Time Frame: Baseline and at 3 years' follow-up
Blood sample (markers describing undernourishment, more precise description before study)
Baseline and at 3 years' follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Virve Kekkonen, M.D., Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ANBA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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