Metabolic Phenotyping in Anorexia Nervosa | NCT02087280

Studies
Metabolic Phenotyping in Anorexia Nervosa

NCT02087280

Sponsor

Charite University, Berlin, Germany

Status

Withdrawn

Last Update Posted

Feb 13, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Anorexia Nervosa

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HA 7034/2-1	Other Identifier	Deutsche Forschungsgemeinschaft

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We did not receive funding

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jan 3, 2014

First Submission Date that Met QC Criteria

Mar 12, 2014

First Posted Date

Mar 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2017

Last Update Posted Date

Feb 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Verena Haas, Dr. oec. troph. Verena Haas, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
Deutsche Forschungegemeinschaft	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relapse		1 year after discharge

Secondary Outcomes

Measure	Description	Time Frame
Metabolic phenotype		Baseline (during inpatient stay)
Biomarkers		Baseline (during inpatient stay)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Female adolescents with Anorexia Nervosa

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Verena K Haas, PhD	Charité University Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité University Clinic		Berlin			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29867616	Derived	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.

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders