BIOANNA: Novel Targetable BIOmarkers in ANorexia NervosA

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05885724

Collaborator

University of Zurich (Other)

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall aim of this present study is to evaluate Growth Differentiation Factor-15 (GDF-15) and inflammatory cytokines as a possible novel and readily treatable target for the successful therapy of Anorexia Nervosa (AN). Therefore, GDF-15, neuronal and glial damage markers such as Neurofilament light chain (Nfl) and Glial fibrillary acidic protein (GFAP) and cytokines (such as Tumor necrosis factor alpha (TNF-α), Interleukin-6 (IL-6), and Interleukin 1β (IL-1β) levels will be assessed in the serum as well as in the cerebrospinal fluid of patients with diagnosed restrictive AN with and without exercising behavior compared to sex- and age-matched healthy controls to consolidate previous findings and to identify the main site of production of GDF-15 and cytokines in AN.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa Anorexia Nervosa Restricting Type

Detailed Description

In addition, assessment of body composition via Dual Energy X-ray Absorptiometry (DEXA )scans and of energy expenditure via indirect calorimetry, respectively, will allow us to correlate GDF-15, Nfl and GFAP and cytokine levels with lean and fat mass measures as well as with energy expenditure, respectively, of AN patients and the matched controls. Overall, this will allow us to comprehensively evaluate GDF-15 and cytokines as possible novel targets for the treatment of AN and to set the basis for a follow up study using available neutralizing antibodies or inhibitors against GDF-15 and the respective cytokines for the treatment of patients with AN, respectively. This will also allow for a more tailored, individualized treatment approach of AN in the future. Our findings will hopefully challenge the viewpoint that AN is a condition which can be controlled by the individual but demonstrate that AN is a biological disease that should be treated by targeting the right biological players in addition to psychiatric treatment.

Study Design

Study Type:

Observational

Anticipated Enrollment :

32 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Outcome Measures

Primary Outcome Measures

Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the plasma [one time assessment 3 weeks after screening]
Comparison of GDF-15 (pg/ml) level in the plasma of AN patients and normal-weight controls Blood in overnight-fasted study participants will be taken from a cubital vein and analyzed for GDF-15 (pg/ml)
Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the cerebrospinal fluids [one time assessment 3 weeks after screening]
Comparison of GDF-15 level in the cerebrospinal fluids of AN patients and normal-weight controls. CSF will be analysed only from patients who undergo a liquor puncture as part of their clinical assessment and consent to having taken an extra 5ml. Cerebrospinal fluid (CSF) will then be analysed for GDF-15 (pg/ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

N=8 adult male and female patients with confirmed diagnosis of anorexia nervosa restrictive type, non-exercising subtype

Inclusion criteria:

Age 18-60 years
Written informed consent
BMI 10-16 kg/m2

N=8 adult male and female patients with confirmed diagnosis of anorexia nervosa restrictive type, exercising subtype will be included in this study.

Inclusion criteria:

Age 18-60 years
Written informed consent
BMI 10-16 kg/m2

N=16 control participants, sex- and age-matched to the individual anorexia nervosa patients.

Inclusion criteria:

Age 18-60 years
Written informed consent
BMI 19-24.9 kg/m2

Exclusion Criteria:

Use of antibiotics within the last 31 days
Current illicit drug abuse including daily marijuana or CBD (cannabidiol) consumption (≤ 24 g of alcohol per day allowed)
Any kind of severe chronic disease other than AN (e.g. active cancer disease)
Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2) if resulting from another disease than AN
Known liver cirrhosis or other severe liver impairment if resulting from another disease than AN
Acute upper respiratory tract infection within the last 31 days
Uncontrolled dysthyroidism
Uncontrolled hypertension
Current pregnancy/lactation or current treatment for in vitro fertilization
Inability to understand the study information, to sign the consent form and to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.