Clinical trial NCT05627583: Nutritional Rehabilitation and Markers of Severity in Anorexia Nervosa
Official title: Τhe Effect of Nutritional rEhabilitation in Patients With Anorexia Nervosa on Markers Associated With Disease severiTy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: Sismanoglio General Hospital
name: Attikon Hospital
name: National Hellenic Research Foundation
First posted: 2022-11-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 13 Males and females with AN who are hospitalized for rehabilitation

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

Eligibility criteria: Inclusion Criteria:

• Patients with Anorexia Nervosa according to the DSM-V (American Psychiatric Association, 2013)

Exclusion criteria:

• Antibiotic treatment before and during the study

Primary outcomes:
measure: Increase in Body Weight
timeFrame: Up to three months during inpatient rehabilitation
Secondary outcomes:
measure: Metabolic recovery in patients with AN
timeFrame: Up to three months during inpatient rehabilitation
measure: Changes in ghrelin levels
timeFrame: Up to three months during inpatient rehabilitation
measure: Changes in blood metals and metalloids
timeFrame: Up to three months during inpatient rehabilitation
measure: Changes in leptin levels
timeFrame: Up to three months during inpatient rehabilitation
measure: Changes in IL-6 levels
timeFrame: Up to three months during inpatient rehabilitation
measure: Changes in serum oxidisability
timeFrame: Up to three months during inpatient rehabilitation
measure: Changes in EDE-Q
timeFrame: Up to three months during inpatient rehabilitation
measure: Changes in EAT-total
timeFrame: Up to three months during inpatient rehabilitation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Kaliora, Andriana C.
state: Attica
Study officials:
affiliation: Harokopio University
name: Andriana C. Kaliora
role: STUDY_DIRECTOR
References: