PROspective Longitudinal All-comer Inclusion Study in Eating Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Eating Disorder NOS. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- GAF-F total score [Time frame: through study completion, an average of 1 year]
- BMI change over time [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- Eating Disorder (ICD-10)
Exclusion criteria
- Forced care/non-voluntary
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Mental Health Center — Ballerup Municipality
Identifiers
NCT: NCT03224091 · PCB-BCRED-1