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Novel Targetable BIOmarkers in ANorexia NervosA

NCT ID: NCT05885724

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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

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Anorexia Nervosa Anorexia Nervosa Restricting Type

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.


* 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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katharina Timper, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Katharina Timper, Prof.

Role: CONTACT

Phone: +41613285742

Email: [email protected]

Valerie Mettraux

Role: CONTACT

Phone: +41613285520

Email: [email protected]

Facility Contacts

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Katharina Timper, Prof.

Role: primary

Valerie Mettraux

Role: backup

Other Identifiers

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2023-00513, kt23Timper2

Identifier Type: -

Identifier Source: org_study_id