Re-nutrition in Severe Anorexia Nervosa (RESAN)
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|ClinicalTrials.gov Identifier: NCT02502617|
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : September 29, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
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.
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.
- 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.
- 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.
- 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
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
|Contact: René K Støving, MD PhDemail@example.com|
|Center for Eating Disorders, Department of Endocrinology, Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: René K Støving, MD, PhD +4565411710 firstname.lastname@example.org|
|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. email@example.com|
|Contact: Simone D Hemmingsen firstname.lastname@example.org|
|Principal Investigator:||René K Støving, MD PhD||Center for Eating Disorders, Odense University Hospital|