An observational study in Anorexia Nervosa, Bulimia Nervosa and Binge-Eating Disorder, sponsored by Mental Health Services in the Capital Region, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Mental Health Services in the Capital Region, Denmark · Observational
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 65 across 104 observational studies indexed under Anorexia.
Browse Anorexia studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients at Psychiatric Center Ballerup with Eating Disorders
Exclusion Criteria:
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mental Health Services in the Capital Region, Denmark