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

Anorexia Nervosa Clinical Trial

— AVAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101538
• Other study ID #: T113/2020
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: December 30, 2027

Study information

• Verified date: November 2021
• Source: Turku University Hospital
• Contact: Pirjo Nuutila, MD,PhD
• Phone: 0401626834
• Email: pirjo.nuutila[@]utu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 32 Years

Eligibility

Inclusion Criteria for AN:

1. Female sex

2. Age 18-32 3 years

3. BMI < 17.5 kg/m2

4. Currently fulfilling modified DSM-IV diagnosis of AN with or without amenorrhea, onset age before 25 years

5. Diagnosed less than 2 years ago

For controls:

1. Female sex

2. Age 18-32 3 years

3. BMI 19 20-25 kg/m2

4. No lifetime history of obesity (BMI => 30) or eating disorders

Exclusion Criteria:

1. Any chronic disease or medication that could affect glucose metabolism or neurotransmission

2. History of psychiatric disorders (excl. AN for the corresponding study group)

3. Smoking of tobacco, taking of snuffs, or use of narcotics

4. Abusive use of alcohol

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Locations

Country	Name	City	State
Finland	Turku PET Centre	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in brain reward system and metabolism in AN patients	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	10 years
Primary	Predictive value of baseline body mass index (BMI), functional brain activation and metabolism in AN	Results from baseline are combined with follow updata	10 y