Energy Turnover in Patients With Anorexia Nervosa | NCT03151135

Studies
Energy Turnover in Patients With Anorexia Nervosa

NCT03151135

Sponsor

Charite University, Berlin, Germany

Status

Terminated

Last Update Posted

May 1, 2019Actual

Enrollment

5Actual

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

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding period expired before all subjects could be recrutied

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Apr 7, 2017

First Submission Date that Met QC Criteria

May 11, 2017

First Posted Date

May 12, 2017Actual

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

Apr 29, 2019

Last Update Posted Date

May 1, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
German Research Foundation	OTHER
Hannover Medical School	OTHER
Ruhr University of Bochum	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AN patients		Patients with Anorexia Nervosa (AN). No intervention, observation at end of inpatient treatment

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting Energy expenditure (REE; kcal/d); Total Daily Energy Expenditure (TDEE; kcal/d)	REE will be measured in a Respiration chamber and TDEE with isotope dilution	End of inpatient treatment (T0), within 2 weeks before discharge

Secondary Outcomes

Measure	Description	Time Frame
Body weight	Body weight 6 months after discharge from inpatient Treatment (T1)	T1 = 6 months after first test (T0)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anorexia nervosa
anabolic metabolism
high compliance
end of inpatient treatment

Exclusion Criteria:

any further disease than eating disorder
smokers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

36 Years

Standard Ages

ChildAdult

Study Population

Patients with Anorexia nervosa

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité-Universitätsmedizin		Berlin		10117	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa

Ancestor Terms

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided