Evaluating biomarkers for treating Anorexia Nervosa

Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA

This study is testing if certain biological markers in people with restrictive Anorexia Nervosa can help find better treatment options by comparing them to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 32 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (other)
• Locations: 1 site (Basel)
• Trial ID: NCT05885724 on ClinicalTrials.gov

What this trial studies

This study aims to assess the levels of Growth Differentiation Factor-15 (GDF-15) and inflammatory cytokines in patients diagnosed with restrictive Anorexia Nervosa, both exercising and non-exercising subtypes. By comparing these levels in patients to those in healthy controls, the study seeks to identify potential biological targets for treatment. Additionally, body composition and energy expenditure will be measured to correlate these biomarkers with physical health metrics. The findings may pave the way for more individualized treatment approaches for Anorexia Nervosa.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-60 with a confirmed diagnosis of restrictive Anorexia Nervosa and a BMI between 10-16 kg/m2.

Not a fit: Patients with severe chronic diseases other than Anorexia Nervosa or those who have used antibiotics recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to novel biological treatments for Anorexia Nervosa, improving patient outcomes.

How similar studies have performed: While the approach of targeting biological markers in Anorexia Nervosa is relatively novel, similar studies in other conditions have shown promise in identifying effective treatments.

Eligibility criteria

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.

Where this trial is running

Basel

• University Hospital Basel — Basel, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Katharina Timper, Prof. — University Hospital, Basel, Switzerland
• Study coordinator: Katharina Timper, Prof.

Conditions: Anorexia Nervosa, Anorexia Nervosa Restricting Type, exercising subtype, non-exercising subtype, Neurofilament light chain, Glial fibrillary acidic protein, Growth Differentiation Factor-15