Novel Targetable BIOmarkers in ANorexia NervosA (BIOANNA)

Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Katharina Timper, Prof.; Phone Number: +41613285742; Email: katharina.timper@usb.ch
• Study Contact Backup: Name: Valerie Mettraux; Phone Number: +41613285520; Email: valerie.mettraux@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Katharina Timper, Prof.; Phone Number: +4161 328 57 42; Email: katharina.timper@usb.ch
    • Contact: Valerie Mettraux; Phone Number: +4161 328 55 20; Email: valerie.mettraux@usb.ch
    • Principal Investigator: Katharina Timper, Prof.
    • Sub-Investigator: Valerie Mettraux
    • Sub-Investigator: Lolita Matiashova, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with confirmed diagnosis of AN will be recruited via the anorexia outpatient clinic of the Endocrinology Department, University Hospital Basel, headed by Prof. Dr. Katharina Timper and via advertisement. Healthy sex- and age (+/- 3 years of age difference) control participants will be recruited at the medical and endocrinology outpatient clinic of the University Hospital of Basel and via advertisement.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Katharina Timper, Prof., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Neurofilament light chain; exercising subtype; non-exercising subtype; Glial fibrillary acidic protein; Growth Differentiation Factor-15
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 2023-00513, kt23Timper2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No