Anorexia NervosaBIOANNANCT05885724
Novel Targetable BIOmarkers in ANorexia NervosA
An observational study of Anorexia Nervosa and Anorexia Nervosa Restricting Type, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Anorexia Nervosa Restricting Type
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with confirmed diagnosis of AN will be recruited via the anorexia outpatient clinic of the Endocrinology Department, University Hospital Basel, headed by Prof. Dr. Katharina Timper and via advertisement. Healthy sex- and age (+/- 3 years of age difference) control participants will be recruited at the medical and endocrinology outpatient clinic of the University Hospital of Basel and via advertisement.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Katharina Timper, Prof., +4161 328 57 42, katharina.timper@usb.ch
Valerie Mettraux, +4161 328 55 20, valerie.mettraux@usb.ch
About this study
Official title: Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA
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.
Read the 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.
- Keywords
- exercising subtype, non-exercising subtype, Neurofilament light chain, Glial fibrillary acidic protein, Growth Differentiation Factor-15
- Medical subject headings
- Anorexia Nervosa, Charcot-Marie-Tooth disease, Type 1F
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the plasma
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)
Measured: one time assessment 3 weeks after screening
Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the cerebrospinal fluids
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)
Measured: one time assessment 3 weeks after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 May 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Katharina Timper, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885724
- Sponsor's protocol ID
- 2023-00513, kt23Timper2
- Other IDs
- 2023
- Acronym
- BIOANNA
- Status last verified
- Dec 2024
- First submitted
- 22 May 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA
- ClinicalTrials.gov ID
- NCT05885724
- Acronym / sponsor ID
- BIOANNA / 2023-00513, kt23Timper2
- Keywords
- exercising subtype, non-exercising subtype, Neurofilament light chain, Glial fibrillary acidic protein, Growth Differentiation Factor-15
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with confirmed diagnosis of AN will be recruited via the anorexia outpatient clinic of the Endocrinology Department, University Hospital Basel, headed by Prof. Dr. Katharina Timper and via advertisement. Healthy sex- and age (+/- 3 years of age difference) control participants will be recruited at the medical and endocrinology outpatient clinic of the University Hospital of Basel and via advertisement.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katharina Timper, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Anorexia Nervosa Restricting Type, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharina Timper, Prof. (+41613285742, katharina.timper@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the plasma (time frame: one time assessment 3 weeks after screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.