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Re-nutrition in Severe Anorexia Nervosa (RESAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502617
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
René Klinkby Støving, Odense University Hospital

Brief Summary:

In anorexia nervosa (AN) it still remains to be clarified, which psychiatric symptoms are the direct consequence of malnutrition and adaptation to starvation and which are not. There is clinical consensus that depression/anxiety and cognitive impairments in AN mainly are sequelae to the malnutrition. However, this consensus is largely based on experimental starvation studies of healthy subjects back in 1940s and from famine- and food programs in the third world, whereas evidence from studies on AN is lacking.

The main objective of the study is in the detail to elucidate the short-term changes in the psychopathological profile, depression, anxiety, and cognitive functions in relations to intensive nutritional rehabilitation with weight gain of 10-30% in a specialized medical stabilization unit. Secondarily, it is examined whether cortisol levels are associated with depression/anxiety symptomatology and cognitive impairments. The hypothesis is that an improvement in nutritional status over a short time leads to clinically significant improvements in psychopathology and cognitive functions, which remain 2-3 months after discharge, making the patients more accessible to psychotherapy.


Condition or disease Intervention/treatment
Anorexia Nervosa Dietary Supplement: medical nutrition

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Intensive Re-nutrition on Eating Disorder Psychopathology, Cognitive Functions, Anxiety, Depression, and Cortisol Level in Severe Anorexia Nervosa
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Weight Improvement
Patients (n = 30) with severe AN, refered to the specialized medical nutrition section at Odense University Hospital are tested three times during nutritional rehabilitation: At admission, at discharge (or drop out) and two-four months after discharge. The first study is carried out not before the third day of hospitalization after acclimatization and water electrolyte correction.
Dietary Supplement: medical nutrition
The participants are expected to improve their body weight with 10-30% during a closely monitored inpatient-treatment comprising nutritional rehabilitation.

Weight-stable
To investigate the re-test effects of the the surveys, outpatients with a stable weight (less than 5%/3 months) with eating disorders (n = 15) are tested twice with 4-6 weeks interval.



Primary Outcome Measures :
  1. Depression/anxiety and cognitive functions composite outcome measure. [ Time Frame: 4-6 months ]
    Depression/anxiety and cognitive functions composite outcome measure. [Time Frame: 4-6 months] [Safety Issue: No] Admission, discharge, and 2-4 months after discharge. Composite outcome measure consisting of the following psychometry: Beck Depression Inventory version 2 (BDI-II), Hospital Anxiety and Depression Scale (HADS), The Perceived Stress Scale (PSS), Wechsler Memory Scale - Third Edition (WMS-III), Wechsler Adult Intelligent Scale-IV, D2 test, Delis-Kaplan Executive Function System (Trail Making Test, Design Fluency Test and Verbal Fluency Test) and Wisconsin Card Sorting Test - Revised. A total score for each of the psychometric subscales will be calculated and tested in pairs with appropriate corrections for multiple testing.


Secondary Outcome Measures :
  1. Eating disorder psychopathology composite outcome measure. [ Time Frame: 4-6 months ]
    Admission, discharge, and 2-4 months after discharge. Composite outcome measure consisting of the following psychometry: Eating Disorder Inventory-3 (EDI-3) and Toronto Alexithymia Scale (TAS-20). A total score for each of the subscales in EDI-3 and for TAS-20 will be calculated and tested in pairs.

  2. Cortisol excretion (nmol Cortisol pr day). [ Time Frame: 4-6 months ]
    Chromatographic mass spectrometric analysis of mixed day urine at admission, discharge, and 2-4 months after discharge.


Biospecimen Retention:   Samples Without DNA
Urine.


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with severe AN referred to a specialized unit.
Criteria

Inclusion criteria:

- Fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AN.

Exclusion Criteria:

  • Patients who can not fill Danish-language questionnaires.
  • Patients who are primarily hospitalized a few days for water electrolyte correction only.
  • Patients with active drug abuse.
  • Patients with co-morbid schizophrenia.
  • Patients where the psychopharmacological treatment qualitative is changed during the study period.

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): NCT02502617


Contacts
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Contact: René K Støving, MD PhD rene.k.stoving@gmail.com

Locations
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Denmark
Center for Eating Disorders, Department of Endocrinology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: René K Støving, MD, PhD    +4565411710    rene.k.stoving@gmail.com   
Principal Investigator: René K Støving, MD PhD         
Sub-Investigator: Mia B Lichtenstein, PhD         
Sub-Investigator: Simone N Hemmingsen, Cand. Psych.         
Sub-Investigator: Kirsten G Hansen         
René Klinkby Støving Recruiting
Odense, Denmark, 5000
Contact: René K Støving, PhD    +4540884486 ext Prof.    rene.stoeving@rsyd.dk   
Contact: Simone D Hemmingsen       rene.stoeving@rsyd.dk   
Sponsors and Collaborators
René Klinkby Støving
Investigators
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Principal Investigator: René K Støving, MD PhD Center for Eating Disorders, Odense University Hospital
Publications:
Beck AT, Steer, R.A., & Brown, G.K. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: René Klinkby Støving, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02502617    
Other Study ID Numbers: RESAN
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be entered in Odense Patient data Explorative Network (OPEN).
Keywords provided by René Klinkby Støving, Odense University Hospital:
Psychopathology
Cognition
Depression
Nutrition
Cortisol
Anorexia nervosa
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders