PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

NCT ID: NCT03224091

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-25

Study Completion Date

2030-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder Eating Disorder NOS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients at Psychiatric Center Ballerup

No interventions assigned to this group

Healthy Controls

No interventions assigned to this group

Healthy Controls recovered from an eating disorder

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Eating Disorder (ICD-10)

Exclusion Criteria

* Forced care/non-voluntary
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Statens Serum Institut

OTHER

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Jan Magnus Sjögren

Research Associate Professor, Sr Consultant Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise Behrend_Rasmussen, MD,PhD

Role: STUDY_CHAIR

Mental Health Center Ballerup

Locations

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Mental Health Center

Ballerup Municipality, Capitol Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Magnus JC Sjögren, MD, PhD

Role: CONTACT

+4538645157

Facility Contacts

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Jan Magnus Sjøgren, MD, ph.d.

Role: primary

+45 3864 5157

Other Identifiers

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PCB-BCRED-1

Identifier Type: -

Identifier Source: org_study_id

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