NCT02087280

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

January 3, 2014

Last Update Submit

February 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relapse

    1 year after discharge

Secondary Outcomes (2)

  • Metabolic phenotype

    Baseline (during inpatient stay)

  • Biomarkers

    Baseline (during inpatient stay)

Study Arms (2)

Anorexia Nervosa

Healthy controls

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Female adolescents with Anorexia Nervosa

You may qualify if:

  • 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

You may not qualify if:

  • Any further disease other than AN with significant influence on body composition and energy metabolism or its assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Clinic

Berlin, Germany

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers of energy metabolism

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Verena K Haas, PhD

    Charité University Berlin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. oec. troph. Verena Haas

Study Record Dates

First Submitted

January 3, 2014

First Posted

March 14, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations