Novel Targetable BIOmarkers in ANorexia NervosA
Recruiting now
Conditions studied: Anorexia Nervosa, Anorexia Nervosa Restricting Type
In brief
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.
Key facts
- Study ID
- NCT05885724
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 32
- Starts
- 2023-05-01
- Expected to finish
- 2025-04-30
- Last updated by the study team
- 2024-12-12
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
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.
- 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
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.
Where it is running
- University Hospital Basel — Basel, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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