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Trial record 28 of 126 for:    Recruiting, Not yet recruiting, Available Studies | "Eating Disorders"

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

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ClinicalTrials.gov Identifier: NCT03224091
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Jan Magnus Sjögren, Mental Health Services in the Capital Region, Denmark

Brief Summary:
The PROLED study is a prospective, longitudinal and naturalistic 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.

Condition or disease
Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder 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, 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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Eating Disorders
Criteria

Inclusion Criteria:

  • Eating Disorder (ICD-10)

Exclusion Criteria:

  • Forced care/non-voluntary

Information from the National Library of Medicine

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


Contacts
Contact: Magnus JC Sjögren, MD, PhD +4538645157 jan.magnus.sjoegren@regionh.dk

Locations
Denmark
Mental Health Center Recruiting
Ballerup, Capitol Region, Denmark, 2750
Contact: Louise Winther-Ankerstierne    +4538644000 ext 4720    louise.winther.ankerstjernexx@regionh.dk   
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Investigators
Study Chair: Louise Behrend_Rasmussen, MD,PhD Mental Health Center Ballerup

Responsible Party: Jan Magnus Sjögren, Research Associate Professor, Sr Consultant Psychiatrist, Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT03224091     History of Changes
Other Study ID Numbers: PCB-BCRED-1
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jan Magnus Sjögren, Mental Health Services in the Capital Region, Denmark:
Eating disorders
psychopathology
pathophysiology
prospective
longitudinal

Additional relevant MeSH terms:
Feeding and Eating Disorders
Binge-Eating Disorder
Disease
Anorexia
Anorexia Nervosa
Bulimia
Bulimia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia