Novel Targetable BIOmarkers in ANorexia NervosA

Anorexia Nervosa Clinical Trial

— BIOANNA  

Official title:

Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885724
• Other study ID #: 2023-00513, kt23Timper2
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Katharina Timper, Prof.
• Phone: +41613285742
• Email: katharina.timper[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anorexia Nervosa Restricting Type

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the plasma	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)	one time assessment 3 weeks after screening
Primary	Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the cerebrospinal fluids	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)	one time assessment 3 weeks after screening