PROspective Longitudinal All-comer Inclusion Study in Eating Disorders (PROLED)

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.

Study Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa; Binge-Eating Disorder; Bulimia Nervosa; Eating Disorder NOS

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Magnus JC Sjögren, MD, PhD; Phone Number: +4538645157; Email: jan.magnus.sjoegren@regionh.dk

Study Locations

• Denmark
  • Capitol Region
    • Ballerup, Capitol Region, Denmark, 2750
      • Recruiting
      • Mental Health Center
      • Contact: Jan Magnus Sjøgren, MD, ph.d.; Phone Number: +45 3864 5157; Email: jan.magnus.sjoegren@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients at Psychiatric Center Ballerup with Eating Disorders

Description

Inclusion Criteria:

• Eating Disorder (ICD-10)

Exclusion Criteria:

• Forced care/non-voluntary

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients at Psychiatric Center Ballerup
Healthy Controls
Healthy Controls recovered from an eating disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 year
cytokines in plasma	Change in inflammatory parameters in blood as a measure of inflammation status	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	through study completion, an average of 1 year
Total score on CogTrac	Change in cognitive performance	through study completion, an average of 1 year
Change in EDI	Change in Eating disorder related behaviour and symptoms	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: University of Copenhagen; University of Southern Denmark; Statens Serum Institut
• Investigators: Study Chair: Louise Behrend_Rasmussen, MD,PhD, Mental Health Center Ballerup

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2016
• Primary Completion (Anticipated): April 1, 2030
• Study Completion (Anticipated): April 1, 2030

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: prospective; Eating disorders; psychopathology; pathophysiology; longitudinal
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Hyperphagia; Anorexia; Anorexia Nervosa; Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
• Other Study ID Numbers: PCB-BCRED-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No