Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03224091

PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anorexia Nervosa Binge-Eating Disorder Bulimia Nervosa Eating Disorder NOS Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mental Health Center

Ballerup Municipality, Capitol Region, 2750, Denmark

Location status: Recruiting

Location contact

Jan Magnus Sjøgren, MD, ph.d.

CONTACT

[email protected]

+45 3864 5157

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eating Disorder (ICD-10)

Exclusion criteria

  • Forced care/non-voluntary

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Total score on CogTrac

    Time frame: through study completion, an average of 1 year

    Change in cognitive performance

  5. Change in EDI

    Time frame: through study completion, an average of 1 year

    Change in Eating disorder related behaviour and symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Magnus JC Sjögren, MD, PhD

CONTACT

[email protected]

+4538645157

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Statens Serum Institut
  • University of Copenhagen
  • University of Southern Denmark

Registry information

Acronym: PROLED

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Jul 21, 2017
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.