Anorexia NervosaNCT03151135
Energy Turnover in Patients With Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with Anorexia nervosa. Read more about this study
- Who is it for?
- Ages 13 to 36 years
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with Anorexia nervosa
Who may be able to join
- Anorexia nervosa
- anabolic metabolism
- high compliance
- end of inpatient treatment
Who cannot join
- any further disease than eating disorder
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anorexia Nervosa
- Keywords
- Energy metabolism
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AN patients | Patients with Anorexia Nervosa (AN). No intervention, observation at end of inpatient treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of inpatient treatment (T0), within 2 weeks before discharge
Secondary outcomes (1)
Body weight
Body weight 6 months after discharge from inpatient Treatment (T1)
Measured: T1 = 6 months after first test (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Funding period expired before all subjects could be recrutied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, Hannover Medical School, Ruhr University of Bochum
- Responsible party
- Principal investigator, Dr. Verena Haas, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151135
- Sponsor's protocol ID
- DLW_AN
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2017
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Energy Turnover After Short-term Nutritional Recovery Predict Subsequent Weight Course in Patients With Anorexia Nervosa?
- ClinicalTrials.gov ID
- NCT03151135
- Acronym / sponsor ID
- DLW_AN
- Conditions
- Anorexia Nervosa
- Keywords
- Energy metabolism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding period expired before all subjects could be recrutied
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation, Hannover Medical School, Ruhr University of Bochum
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with Anorexia nervosa.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AN patients | – | –Patients with Anorexia Nervosa (AN). No intervention, observation at end of inpatient treatment |
Who may qualify
- Ages
- 13 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with Anorexia nervosa
Key inclusion criteria (4 listed)
- Anorexia nervosa
- anabolic metabolism
- high compliance
- end of inpatient treatment
Key exclusion criteria (2 listed)
- any further disease than eating disorder
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Body weight
Time frame: T1 = 6 months after first test (T0)
Results and safety
The study was stopped early (reason given: Funding period expired before all subjects could be recrutied). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding period expired before all subjects could be recrutied). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.