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Region Hovedstaden - en del af Københavns Universitetshospital

Prospective Longitudinal All-comer Inclusion study in Eating Disorders

Projekt: Typer af projekter

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The PROLED study is a longitudinal naturalistic clinical study that is collecting data from clinical questionaires, various tests and interviews, that are done on patients with ED at the Mental Health Center Ballerup (MHCB). In addition, biological samples (plasma, serum, faeces) are collected from the patients. Data will cover clinical, behavioral, emotional, cognitive and personality characterization on all ED patients included, and MRI, and EEG from a subset with ED. PROLED commenced in January 2016 and will continue for 10. The aim is to include 1000 patients with ED. In Denmark, the prevalence of AN alone is at least 19500 individuals. In the catchment area of MHCB there are approximately 3250 AN patients. In 2014, MHCB treated approximately 380 individuals with ED

This is a prospective and longitudinal study, where all patients treated and/or investigated at the hospital unit, are offered to be enrolled in the PROLED study. Hereby, it is a naturalistic study, following up on the progression of the disorder, characterizing patients cross-sectionally at baseline, with a thorough medical history, clinical questionnaires and tests and interviews, collecting data from medical records, blood sample drawing, and collection of urine and feces. In addition, collection of biological samples and psychological tests are done at annually follow-ups to enable a longitudinally characterization of the psychopathology and biological changes over time in patients with eating disorders. All included patients are above 17 and below 66 years.

In addition, there is a control study, which will investigate healthy volunteers in the same age range, matched for age and gender, but with a normal BMI, however in the lower range, in relation to the patient population. The same investigations are done on healthy volunteers at one occasion.

Investigations, clinical
All patients and healthy volunteers go through a battery of self-rating scales, which include the following domains: eating disorders, depression, anxiety, obsessive-compulsive, personality disorder, cognition, autism, previous trauma, social relations, previous treatment, global functioning, and quality of life. In addition, patients are rated by physicians for severity of eating disorder, depression, anxiety, obsessive compulsiveness, and global function. Moreover, the patients undergo cognitive testing with the CogTrac, a computerized cognitive test battery.

Blood samples are collected from all patients and healthy volunteers. In total, three blood tubes are collected: One lithium heparin, one EDTA, and one PAX tube. In addition, urine and feces are collected.


  • Sundhedsvidenskab - Eating Disorders, Biomarkers, Observational study

ID: 49127360