Anorexia Nervosa, Binge-Eating Disorder, Bulimia Nervosa, Eating Disorder NOS
Conditions
Keywords
Eating disorders, psychopathology, pathophysiology, prospective, longitudinal
Brief 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. 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.
Interventions
None listed
Sponsors
University of Southern Denmark
University of Copenhagen
Statens Serum Institut
Mental Health Services in the Capital Region, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Eating Disorder (ICD-10)
Exclusion criteria
* Forced care/non-voluntary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GAF-F total score | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers in blood | through study completion, an average of 1 year | Change in biomarker parameters in blood as a measure of change in biological parameters |
| MDI | through study completion, an average of 1 year | 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 |
| Change in EDI | through study completion, an average of 1 year | Change in Eating disorder related behaviour and symptoms |
| Total score on CogTrac | through study completion, an average of 1 year | Change in cognitive performance |
| cytokines in plasma | through study completion, an average of 1 year | Change in inflammatory parameters in blood as a measure of inflammation status |
Countries
Denmark
Contacts
Primary ContactMagnus JC Sjögren, MD, PhD
Outcome results
None listed