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.
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 Type
OBSERVATIONAL
Enrollment
1,000
Mental Health Center
Ballerup Municipality, Capitol Region, Denmark
RECRUITINGGAF-F total score
Change in Global level of functioning will be assessed using the GAF-F score for the whole population of treated individuals
Time frame: 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
Time frame: through study completion, an average of 1 year
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
Time frame: through study completion, an average of 1 year
cytokines in plasma
Change in inflammatory parameters in blood as a measure of inflammation status
Time frame: 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
Time frame: through study completion, an average of 1 year
Total score on CogTrac
Change in cognitive performance
Time frame: through study completion, an average of 1 year
Change in EDI
Change in Eating disorder related behaviour and symptoms
Time frame: through study completion, an average of 1 year
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