Kaliora, Andriana C.
Athens, Attica, Greece
NCT Number: NCT05627583
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.
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Notify Me18 year and older
All sexes
Observational
Athens, Attica, Greece
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hospitalized patients with AN under treatment for rehabilitation
Time frame: Up to three months during inpatient rehabilitation
Increase in body weight as a marker of rehabilitation
Time frame: 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.
Time frame: Up to three months during inpatient rehabilitation
As a marker of appetite ghrelin blood levels are measured.
Time frame: Up to three months during inpatient rehabilitation
Different metals and metalloids in plasma are evaluated applying ICP-MS.
Time frame: Up to three months during inpatient rehabilitation
Changes in leptin levels
Time frame: Up to three months during inpatient rehabilitation
Changes in IL-6 levels
Time frame: Up to three months during inpatient rehabilitation
Changes in serum oxidisability
Time frame: Up to three months during inpatient rehabilitation
The EDE-Q is a marker of disorder severity.
Time frame: Up to three months during inpatient rehabilitation
EAT-total is a marker of disorder severity.
Harokopio University
Other
Τhe Effect of Nutritional rEhabilitation in Patients With Anorexia Nervosa on Markers Associated With Disease severiTy
Acronym: EAT
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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.
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