- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03151135
Energy Turnover in Patients With Anorexia Nervosa
April 29, 2019 updated by: Dr. Verena Haas, Charite University, Berlin, Germany
Does Energy Turnover After Short-term Nutritional Recovery Predict Subsequent Weight Course in Patients With Anorexia Nervosa?
Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with Anorexia nervosa.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10117
- Charité-Universitätsmedizin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 36 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with Anorexia nervosa
Description
Inclusion Criteria:
- Anorexia nervosa
- anabolic metabolism
- high compliance
- end of inpatient treatment
Exclusion Criteria:
- any further disease than eating disorder
- smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
AN patients
Patients with Anorexia Nervosa (AN).
No intervention, observation at end of inpatient treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting Energy expenditure (REE; kcal/d); Total Daily Energy Expenditure (TDEE; kcal/d)
Time Frame: End of inpatient treatment (T0), within 2 weeks before discharge
|
REE will be measured in a Respiration chamber and TDEE with isotope dilution
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End of inpatient treatment (T0), within 2 weeks before discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight
Time Frame: T1 = 6 months after first test (T0)
|
Body weight 6 months after discharge from inpatient Treatment (T1)
|
T1 = 6 months after first test (T0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
April 7, 2017
First Submitted That Met QC Criteria
May 11, 2017
First Posted (Actual)
May 12, 2017
Study Record Updates
Last Update Posted (Actual)
May 1, 2019
Last Update Submitted That Met QC Criteria
April 29, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLW_AN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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