Nutritional Rehabilitation and Markers of Severity in Anorexia Nervosa
- Conditions
- Anorexia Nervosa
- Interventions
- Other: Rehabilitation
- Registration Number
- NCT05627583
- Lead Sponsor
- Harokopio University
- Brief Summary
The design of this project is a longitudinal trial in patients with Anorexia Nervosa (AN) during in-hospital rehabilitation. Τhe structure of the study, the questionnaires and data protection policy prepared exclusively for our study, have been reviewed and standardised at Institutional Review Boards (Ethics Committees, IRBs,) in Harokopio University of Athens (HUA), Eginition Hospital (EH), Attiko Hospital (AH) and Sismanoglio Hospital (SG).
AN is a psychiatric disorder followed by a psychopathologic concerning of body image and very low body weight due to extreme self-starvation. The exact pathogenesis of AN remains unknown with neurobiological, gastrointestinal, neuroendocrinological, immunological, and genetic factors suspected to be implicated. Furthermore, many metabolic traits, biochemical, biological or/and anthropometrical, are manifested during the maintaining effort of patients to achieve lower body weight. Self-inflicted starvation is the primary and essential causation of the pathological outcomes of the disorder. These outcomes involve all biological systems and organs. The role of the immune system in AN is critical as levels of pro-inflammatory cytokines are increased and the immune system is dysregulated. Other contributors to AN pathogenesis have been proposed, such as increased oxidative stress, dysbiosis of the gut microbiota and altered metabolomic profiles. Treatment options for patients with AN constitutes outpatient and inpatient care accordingly with the severity of the disorder. So far, no biomarker has been strongly proposed as an indicator of the disorder's severity or for assessing the progression of the treatment.
The purpose of this study is to assess and monitor the nutritional rehabilitation of patients with AN during hospitalization treatment. Throughout the treatment's course, nutrition and feeding process, vital signs, psychopathology and biological samples will be gathered and statistical analysis of these data is expected to reveal potential biomarker/s for monitoring the progression of recovery.
- Detailed Description
Inpatients with AN and non-eating disorders control subjects will be informed about the project outline, objectives and inclusion criteria.
Monitoring of AN patients will take place during in-hospital rehabilitation. Physical exam, lab tests, bioelectrical impedance analysis and psychometric evaluation will take place twice a month. Plasma and serum will be collected and isolated form blood samples, while stool samples will be collected for Nuclear Magnetic Resonance (NMR) metabolomics analysis and in StoolFix tubes for DNA isolation from intestinal microbiota. For serum and plasma isolation, whole blood will be directly and properly drawn into a vacutainer tube and promptly centrifuged. Then, samples will be stored at -80C until further elaboration. Case record forms will be carefully checked for missing data and inconsistencies prior to developing a proper database based on data entry. The highest ethical standards and data protection will be considered.
Assessment will include Medical history, Anthropometric measurements, Vital signs, Nutrition, Subjective Global Assessment-Patient Generated (SGA-PG), Biochemical parameters, Appetite hormones, Inflammation markers, Oxidative stress markers, Composition of intestinal microbiota, Psychometric scales-measurements, Eating Attitude Test-26 (EAT-26), Eating Disorder Examination Questionnaire (EDE-Q), Spielberger State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Body Appreciation Scale (BAS), Sense of Coherence Scale (SOC), Visual Analogue Scale (VAS) for subjective appetite estimation
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
• Patients with Anorexia Nervosa according to the DSM-V (American Psychiatric Association, 2013)
Exclusion criteria:
• Antibiotic treatment before and during the study
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anorexia Nervosa (AN) Rehabilitation Anorexia Nervosa patients hospitalized for rehabilitation
- Primary Outcome Measures
Name Time Method Increase in Body Weight Up to three months during inpatient rehabilitation Increase in body weight as a marker of rehabilitation
- Secondary Outcome Measures
Name Time Method Changes in blood metals and metalloids Up to three months during inpatient rehabilitation Different metals and metalloids in plasma are evaluated applying ICP-MS.
Changes in IL-6 levels Up to three months during inpatient rehabilitation Changes in IL-6 levels
Changes in serum oxidisability Up to three months during inpatient rehabilitation Changes in serum oxidisability
Metabolic recovery in patients with AN Up to three months during inpatient rehabilitation This study aims to investigate metabolic changes in the gut microbiome of patients with Anorexia Nervosa during nutritional rehabilitation. Stool samples will be collected at multiple time points throughout the in-hospital rehabilitation period. Metabolite concentrations will be analyzed using Nuclear Magnetic Resonance (NMR)-based metabolomics to assess longitudinal alterations associated with metabolic recovery.
Changes in ghrelin levels Up to three months during inpatient rehabilitation As a marker of appetite ghrelin blood levels are measured.
Changes in leptin levels Up to three months during inpatient rehabilitation Changes in leptin levels
Changes in EDE-Q Up to three months during inpatient rehabilitation The EDE-Q is a marker of disorder severity.
Changes in EAT-total Up to three months during inpatient rehabilitation EAT-total is a marker of disorder severity.
Trial Locations
- Locations (1)
Kaliora, Andriana C.
🇬🇷Athens, Attica, Greece