PROspective Longitudinal All-comer Inclusion Study in Eating Disorders (PROLED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03224091|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
|Condition or disease|
|Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder Eating Disorder Nos|
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, longitudinal and naturalistic. Qualitative interviews, psychometric tests, questionnaires are used to collect data on psychopathology. There is also collection of blood, urine and faeces.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||PROspective Longitudinal All-comer Inclusion Study in Eating Disorders|
|Actual Study Start Date :||January 25, 2016|
|Estimated Primary Completion Date :||January 31, 2026|
|Estimated Study Completion Date :||June 30, 2026|
- 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
- MDI [ Time Frame: 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
- cytokines in plasma [ Time Frame: through study completion, an average of 1 year ]Change in inflammatory parameters in blood as a measure of inflammation status
- Biomarkers in blood [ Time Frame: through study completion, an average of 1 year ]Change in biomarker parameters in blood as a measure of change in biological parameters
- Total score on CogTrac [ Time Frame: through study completion, an average of 1 year ]Change in cognitive performance
- Change in EDI [ Time Frame: through study completion, an average of 1 year ]Change in Eating disorder related behaviour and symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224091
|Contact: Magnus JC Sjögren, MD, PhDemail@example.com|
|Mental Health Center||Recruiting|
|Ballerup, Capitol Region, Denmark, 2750|
|Contact: Louise Winther-Ankerstierne +4538644000 ext 4720 firstname.lastname@example.org|
|Study Chair:||Louise Behrend_Rasmussen, MD,PhD||Mental Health Center Ballerup|