Anorexia NervosaPROLEDNCT03224091
PROspective Longitudinal All-comer Inclusion Study in Eating Disorders
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The PROLED study is a prospective and longitudinal study of patients with Eating Disorders. Annual interviews and collection of biological samples are done, as well as during changes in disease course e.g. during hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Jan 2016to 1 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at Psychiatric Center Ballerup with Eating Disorders
Who may be able to join
- Eating Disorder (ICD-10)
Who cannot join
- Forced care/non-voluntary
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Center
Ballerup Municipality, Capitol Region, 2750
Jan Magnus Sjøgren, MD, ph.d., +45 3864 5157, jan.magnus.sjoegren@regionh.dk
About this study
The PROLED study is a prospective and longitudinal study of patients with Eating Disorders. Annual interviews and collection of biological samples are done, as well as during changes in disease course e.g. during hospitalization. Included are qualitative interviews, psychometric tests, questionnaires which are used to collect data on psychopathology. There is also collection of blood, urine and faeces.
Read the detailed description
The objective is to increase the understanding of the psychopathology and pathophysiology of Eating Disorders.
More specifically, the aim is to identify biomarkers that relate to prognosis, disease course and response to treatment as usual of Eating Disorders, and, to improve the understanding of the pathophysiology of Eating disorders in order to identify novel molecular targets for treatment.
Rationale The etiology of Eating Disorders (ED's) is unknown. Previous studies have identified genes that link Anorexia Nervosa to other psychiatric (e.g. schizophrenia) and somatic disorders (e.e. diabetes). Association studies have also suggested genetic causes underlying Bulimia Nervosa and Binge Eating Disorders. The PROLED study aims to improve the understanding of both the psychopathology and pathophysiology of Eating Disorders. No experimental drug will be used in this study.
There is a great need for an increased biological understanding of ED's in view of the prevalence, the costs, the severity and high mortality rates, and the lack of efficient treatments. The PROLED study aims to answer questions related to these unmet medical needs.
The study design is prospective and longitudinal. Qualitative interviews, psychometric tests, questionnaires are used to collect data on psychopathology. There is also collection of blood, urine and faeces.
- Keywords
- Eating disorders, psychopathology, pathophysiology, prospective, longitudinal
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Feeding and Eating Disorders
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 at Psychiatric Center Ballerup | Not described | |
| Healthy Controls | Not described | |
| Healthy Controls recovered from an eating disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAF-F total score
Change in Global level of functioning will be assessed using the GAF-F score for the whole population of treated individuals
Measured: through study completion, an average of 1 year
BMI change over time
Change in Body Mass Index (BMI) will be assess in the whole population of Anorexia Nervosa patients and compared to other diagnoses and Healthy controls, change over time
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
MDI
Change in Major Depressive Inventory will be used to assess depressiveness, assessed for all patients with one diagnosis and compared to other diagnoses and healthy controls; change over time
Measured: through study completion, an average of 1 year
cytokines in plasma
Change in inflammatory parameters in blood as a measure of inflammation status
Measured: through study completion, an average of 1 year
Biomarkers in blood
Change in biomarker parameters in blood as a measure of change in biological parameters
Measured: through study completion, an average of 1 year
Total score on CogTrac
Change in cognitive performance
Measured: through study completion, an average of 1 year
Change in EDI
Change in Eating disorder related behaviour and symptoms
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start25 Jan 2016
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, University of Copenhagen, Statens Serum Institut
- Responsible party
- Principal investigator, Jan Magnus Sjögren, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Louise Behrend_Rasmussen, MD,PhD, Study chair, Mental Health Center Ballerup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224091
- Sponsor's protocol ID
- PCB-BCRED-1
- Acronym
- PROLED
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2017
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Longitudinal All-comer Inclusion Study in Eating Disorders
- ClinicalTrials.gov ID
- NCT03224091
- Acronym / sponsor ID
- PROLED / PCB-BCRED-1
- Keywords
- Eating disorders, psychopathology, pathophysiology, prospective, longitudinal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, University of Copenhagen, Statens Serum Institut
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 21 Jul 2017 (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 PROLED study is a prospective and longitudinal study of patients with Eating Disorders. Annual interviews and collection of biological samples are done, as well as during changes in disease course e.g. during hospitalization. Included are qualitative interviews, psychometric tests, questionnaires which are used to collect data on psychopathology. There is also collection of blood, urine and faeces.
Detailed description
The objective is to increase the understanding of the psychopathology and pathophysiology of Eating Disorders.
More specifically, the aim is to identify biomarkers that relate to prognosis, disease course and response to treatment as usual of Eating Disorders, and, to improve the understanding of the pathophysiology of Eating disorders in order to identify novel molecular targets for treatment.
Rationale The etiology of Eating Disorders (ED's) is unknown. Previous studies have identified genes that link Anorexia Nervosa to other psychiatric (e.g. schizophrenia) and somatic disorders (e.e. diabetes). Association studies have also suggested genetic causes underlying Bulimia Nervosa and Binge Eating Disorders. The PROLED study aims to improve the understanding of both the psychopathology and pathophysiology of Eating Disorders. No experimental drug will be used in this study.
There is a great need for an increased biological understanding of ED's in view of the prevalence, the costs, the severity and high mortality rates, and the lack of efficient treatments. The PROLED study aims to answer questions related to these unmet medical needs.
The study design is prospective and longitudinal. Qualitative interviews, psychometric tests, questionnaires are used to collect data on psychopathology. There is also collection of blood, urine and faeces.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients at Psychiatric Center Ballerup | – | – |
| Healthy Controls | – | – |
| Healthy Controls recovered from an eating disorder | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Psychiatric Center Ballerup with Eating Disorders
Key inclusion criteria (1 listed)
- Eating Disorder (ICD-10)
Key exclusion criteria (1 listed)
- Forced care/non-voluntary
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
GAF-F total score
Time frame: through study completion, an average of 1 year
Change in Global level of functioning will be assessed using the GAF-F score for the whole population of treated individuals
BMI change over time
Time frame: through study completion, an average of 1 year
Change in Body Mass Index (BMI) will be assess in the whole population of Anorexia Nervosa patients and compared to other diagnoses and Healthy controls, change over time
5 secondary outcomes
MDI
Time frame: through study completion, an average of 1 year
cytokines in plasma
Time frame: through study completion, an average of 1 year
Biomarkers in blood
Time frame: through study completion, an average of 1 year
Total score on CogTrac
Time frame: through study completion, an average of 1 year
Change in EDI
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Louise Behrend_Rasmussen, MD,PhD study chair
Mental Health Center Ballerup
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 and Bulimia Nervosa, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Apr 2022. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus JC Sjögren, MD, PhD (+4538645157, jan.magnus.sjoegren@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAF-F total score (time frame: through study completion, an average of 1 year). 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 7 Apr 2022.