Anorexia NervosaNCT02087280
Metabolic Phenotyping in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as lack of the patient's compliance and motivation to recover. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Female adolescents with Anorexia Nervosa
Who may be able to join
- Diagnosis of Anorexia Nervosa
- Between 12 and 18 years of age
- Written and informed consent of patient and parents
- Mental ability to understand the concept of the study
- Inpatient admission to Charité University Clinic with body weight below the 10th BMI-Percentile
Who cannot join
- Any further disease other than AN with significant influence on body composition and energy metabolism or its assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Phenotyping to Predict Risk of Relapse in Patients With Anorexia Nervosa
After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as lack of the patient's compliance and motivation to recover. However in studies, psychological relapse predictors explain only a minor part of the variance in relapse risk. Metabolic phenotyping has clinical value to predict weight course in obese patients and we assume that it could also be clinically relevant in patients with AN. We hypothesize that in patients with a dissipative but not with the thrifty phenotype, positive energy balance during refeeding causes an over proportional rise in energy expenditure, counteracts continuous weight gain during inpatient treatment, and increases relapse risk within one year after discharge. Thus we believe that metabolic phenotype as a biological parameter has prognostic value for the disease course in AN.
- Conditions
- Anorexia Nervosa
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Measured: 1 year after discharge
Secondary outcomes (2)
Metabolic phenotype
Measured: Baseline (during inpatient stay)
Biomarkers
Measured: Baseline (during inpatient stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: We did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Forschungegemeinschaft
- Responsible party
- Principal investigator, Dr. Verena Haas, Charite University, Berlin, Germany
- Investigators
- Verena K Haas, PhD, Principal investigator, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087280
- Sponsor's protocol ID
- VHaas
- Other IDs
- HA 7034/2-1
- Status last verified
- Feb 2017
- First submitted
- 3 Jan 2014
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Haas V, Stengel A, Mahler A, Gerlach G, Lehmann C, Boschmann M, de Zwaan M, Herpertz S. Metabolic Barriers to Weight Gain in Patients With Anorexia Nervosa: A Young Adult Case Report. Front Psychiatry. 2018 May 18;9:199. doi: 10.3389/fpsyt.2018.00199. eCollection 2018.
PubMed 29867616
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Phenotyping to Predict Risk of Relapse in Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02087280
- Acronym / sponsor ID
- VHaas
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutsche Forschungegemeinschaft
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Mar 2014 (estimated)
- 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.
After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as lack of the patient's compliance and motivation to recover. However in studies, psychological relapse predictors explain only a minor part of the variance in relapse risk. Metabolic phenotyping has clinical value to predict weight course in obese patients and we assume that it could also be clinically relevant in patients with AN. We hypothesize that in patients with a dissipative but not with the thrifty phenotype, positive energy balance during refeeding causes an over proportional rise in energy expenditure, counteracts continuous weight gain during inpatient treatment, and increases relapse risk within one year after discharge. Thus we believe that metabolic phenotype as a biological parameter has prognostic value for the disease course in AN.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Female adolescents with Anorexia Nervosa
Key inclusion criteria (5 listed)
- Diagnosis of Anorexia Nervosa
- Between 12 and 18 years of age
- Written and informed consent of patient and parents
- Mental ability to understand the concept of the study
- Inpatient admission to Charité University Clinic with body weight below the 10th BMI-Percentile
Key exclusion criteria (1 listed)
- Any further disease other than AN with significant influence on body composition and energy metabolism or its assessment
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
Relapse
Time frame: 1 year after discharge
2 secondary outcomes
Metabolic phenotype
Time frame: Baseline (during inpatient stay)
Biomarkers
Time frame: Baseline (during inpatient stay)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Derived from this study: PubMed 29867616Haas V, Stengel A, Mahler A, Gerlach G, Lehmann C, Boschmann M, de Zwaan M, Herpertz S. Metabolic Barriers to Weight Gain in Patients With Anorexia Nervosa: A Young Adult Case Report. Front Psychiatry. 2018 May 18;9:199. doi: 10.3389/fpsyt.2018.00199. eCollection 2018.
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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. This study is not recruiting at the moment.
Verena K Haas, PhD principal investigator
Charité University Berlin
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, run by Charite University, Berlin, Germany at 1 site in Germany.
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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Feb 2017. 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 Germany. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: 1 year after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02087280, which also lists 1 linked publication.
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 13 Feb 2017.