NCT03151135

Brief Summary

Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with Anorexia nervosa.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

April 7, 2017

Last Update Submit

April 29, 2019

Conditions

Keywords

Energy metabolism

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Body weight

    T1 = 6 months after first test (T0)

Study Arms (1)

AN patients

Patients with Anorexia Nervosa (AN). No intervention, observation at end of inpatient treatment

Eligibility Criteria

Age13 Years - 36 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with Anorexia nervosa

You may qualify if:

  • Anorexia nervosa
  • anabolic metabolism
  • high compliance
  • end of inpatient treatment

You may not qualify if:

  • any further disease than eating disorder
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité-Universitätsmedizin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

April 7, 2017

First Posted

May 12, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations