Novel Targetable BIOmarkers in ANorexia NervosA

NCT05885724 | Recruiting

• 1 other identifier: 2023-00513, kt23Timper2
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Anorexia Nervosa Restricting Type

Keywords

exercising subtype; non-exercising subtype; Neurofilament light chain; Glial fibrillary acidic protein; Growth Differentiation Factor-15

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Zurich: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Anorexia Nervosa; Charcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Katharina Timper, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Timper, Prof.

CONTACT

+41613285742; katharina.timper@usb.ch

Valerie Mettraux

CONTACT

+41613285520; valerie.mettraux@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 2, 2023
• Study Start: May 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CH (1)