NCT05101538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

October 12, 2021

Last Update Submit

December 12, 2024

Conditions

Keywords

Anorexia nervosametabolismfunctional imagingPET

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

patients and controls

AN patients and controls are recruited, studied using imaging and followed for 5 years

Eligibility Criteria

Age18 Years - 32 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAN is more frequent in females, rare in males.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Totallly 30 female subjects with anorexia nervosa are recuited from the Eating Disorder Unit at the Turku University Hospital who meet the following criteria: i) modified DSM-IV diagnosis of AN with or without amenorrhea; ii) AN onset before the age of 25 years; iii) age between 18 and 32 3 years; iv) no lifetime history of binge eating. Their data are compared with 30 age and sex-matched healthy controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre

Turku, 20521, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Pirjo Nuutila, MD, PhD

    Turku PET Centre, Turku University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 1, 2021

Study Start

November 1, 2020

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations