Anorexia NervosaAVAIN-PETNCT05101538
Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction
An observational study of Anorexia Nervosa, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 25 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2020to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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:
Show all 10Show fewer
- Female sex
- Age 18-32 3 years
- BMI 19 20-25 kg/m2
- No lifetime history of obesity (BMI ≥> 30) or eating disorders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anorexia Nervosa and it's Effects on Brain Function, Body Metabolism and Their Interaction
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, metabolism, functional imaging, PET
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients and controls | AN patients and controls are recruited, studied using imaging and followed for 5 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10 y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pirjo Nuutila, Turku University Hospital
- Investigators
- Pirjo Nuutila, MD, PhD, Principal investigator, Turku PET Centre, Turku University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101538
- Sponsor's protocol ID
- T113/2020
- Acronym
- AVAIN-PET
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anorexia Nervosa and it's Effects on Brain Function, Body Metabolism and Their Interaction
- ClinicalTrials.gov ID
- NCT05101538
- Acronym / sponsor ID
- AVAIN-PET / T113/2020
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, metabolism, functional imaging, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients and controls | – | –AN patients and controls are recruited, studied using imaging and followed for 5 years |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in brain reward system and metabolism in AN patients
Time frame: 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
Time frame: 10 y
Results from baseline are combined with follow updata
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pirjo Nuutila, MD, PhD principal investigator
Turku PET Centre, Turku University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain reward system and metabolism in AN patients (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.