AVAIN: Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction

Sponsor

Turku University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05101538

Collaborator

(none)

Enrollment

Location

85.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The neuromolecular and metabolic underpinnings of Anorexia Nervosa (AN) are studied using multi-modal molecular (positron emission tomography with two different radioligands) and functional (functional magnetic resonance imaging) neuroimaging in a prospective design. Subjects with AN and normal weight adolescents will be studied with PET and MRI and followed for five years.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa

Detailed Description

A total of sixty females (30 with AN, 30 healthy controls) are recruited into this prospective study. The subjects will undergo physical examination, body tissue composition measurement, functional and structural MRI of the brain and body, and positron emission tomography (PET) with ligands [18F]-FDG, and [11C]carfentanil. Subjects' weight and physical condition will be followed up for 5 years. The study will start in August 2020 and end in the fall of 2028.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Anorexia Nervosa and it's Effects on Brain Function, Body Metabolism and Their Interaction

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 30, 2027

Anticipated Study Completion Date :

Dec 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
patients and controls AN patients and controls are recruited, studied using imaging and followed for 5 years

Outcome Measures

Primary Outcome Measures

Changes in brain reward system and metabolism in AN patients [10 years]
AN patients and controls are studied using fMRI and PET imaging and followed 10 years. Reward system function is measured using functional MRI and metabolism using 18F-fluorodeoxy glucose and PETCT imaging
Predictive value of baseline body mass index (BMI), functional brain activation and metabolism in AN [10 y]
Results from baseline are combined with follow updata

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 32 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for AN:

Female sex
Age 18-32 3 years
BMI < 17.5 kg/m2
Currently fulfilling modified DSM-IV diagnosis of AN with or without amenorrhea, onset age before 25 years
Diagnosed less than 2 years ago

For controls:

Female sex
Age 18-32 3 years
BMI 19 20-25 kg/m2
No lifetime history of obesity (BMI ≥> 30) or eating disorders

Exclusion Criteria:

Any chronic disease or medication that could affect glucose metabolism or neurotransmission
History of psychiatric disorders (excl. AN for the corresponding study group)
Smoking of tobacco, taking of snuffs, or use of narcotics
Abusive use of alcohol