Trials / Recruiting
RecruitingNCT05885724
Novel Targetable BIOmarkers in ANorexia NervosA
Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 32 (estimated)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2025-04-30
- Completion
- 2025-04-30
- First posted
- 2023-06-02
- Last updated
- 2024-12-12
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT05885724. Inclusion in this directory is not an endorsement.