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NCT Number: NCT05885724

Novel Targetable BIOmarkers in ANorexia NervosA

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Katharina Timper, Prof.

CONTACT

[email protected]

+4161 328 57 42

Katharina Timper, Prof.

PRINCIPAL_INVESTIGATOR

Lolita Matiashova, Dr. med.

SUB_INVESTIGATOR

Valerie Mettraux

CONTACT

[email protected]

+4161 328 55 20

Valerie Mettraux

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the plasma

    Time frame: 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)

  2. Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the cerebrospinal fluids

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Katharina Timper, Prof.

CONTACT

[email protected]

+41613285742

Valerie Mettraux

CONTACT

[email protected]

+41613285520

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • University of Zurich

Registry information

Official study title

Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA

Acronym: BIOANNA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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