Anorexia NervosaNCT00825461
Ghrelin With Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The PICOWO research group in corporation with the University of Amsterdam (Artificial Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos, Jonker \& Treur, 2003). In a running Phd project we want to add ghrelin to the model. Read more about this study
- Who is it for?
- Ages 12 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to 31 Dec 2012
- 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 12 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Studypopulation: Patiënts: all female, non -age coupled. Subgroup patients without tube feeding, with tube feeding and a healthy matched control group. Control group: healthy volunteers of the University of Maastricht.
Who may be able to join
- Studypopulation: Patiënts: all female, non -age coupled.
- Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.
- Control group: healty volunteers of the University of Maastricht.
Who cannot join
- Patients with a history of eating disorder different than AN or a psychiatric history.
- Control group: no history of eating disorders or other psychiatric disabilities. Normal physical examination, ecg, laboratorium (blood cells, liver, kidneys)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Hospital Maastricht
Maastricht, Limburg, 6202 AZ
About this study
Official title: Level of Ghrelin With Anorexia Nervosa (AN) Patients. Subgroup AN: With and Without Tubefeeding.
The PICOWO research group in corporation with the University of Amsterdam (Artificial Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos, Jonker \& Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea for this current research is to collect clinical information about the functioning and (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.
Read the detailed description
Eating disorders are in need of new perspectives. A better understanding of the appetite in patients with eating disorders, especially Anorexia Nervosa, could be investigated by the levels of ghrelin in patients with and without tube feeding.
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa
- 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 |
|---|---|---|
| 1 | Anorexia with tube feeding | |
| 2 | Anorexia without tube feeding | |
| 3 | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of ghrelin in blood.
Measured: 1 morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine F Delfos, Dr, Principal investigator, PICOWO Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825461
- Sponsor's protocol ID
- 08-3-089
- Status last verified
- Sep 2009
- First submitted
- 20 Jan 2009
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosse, T.; Delfos., M.F.; Jonker, C.M. & Treur, J. (2003). Reasoning about adaptive Dynamical Systems in the Analysis of eating Regulation Disorders. N.J. Mahwah. Proceedings of the 25th Annual Conference of the Cognitive Science Society. Lawrence Erlbaum Associates Inc.
Both, F. & Delfos, M.F. (in preparation). The role of ghrelin in eating disorders, a review.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Ghrelin With Anorexia Nervosa (AN) Patients. Subgroup AN: With and Without Tubefeeding.
- ClinicalTrials.gov ID
- NCT00825461
- Acronym / sponsor ID
- 08-3-089
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 21 Jan 2009 (estimated)
- 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.
The PICOWO research group in corporation with the University of Amsterdam (Artificial Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos, Jonker \& Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea for this current research is to collect clinical information about the functioning and (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.
Detailed description
Eating disorders are in need of new perspectives. A better understanding of the appetite in patients with eating disorders, especially Anorexia Nervosa, could be investigated by the levels of ghrelin in patients with and without tube feeding.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Anorexia with tube feeding |
| 2 | – | –Anorexia without tube feeding |
| 3 | – | –Control |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Studypopulation: Patiënts: all female, non -age coupled. Subgroup patients without tube feeding, with tube feeding and a healthy matched control group. Control group: healthy volunteers of the University of Maastricht.
Key inclusion criteria (3 listed)
- Studypopulation: Patiënts: all female, non -age coupled.
- Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.
- Control group: healty volunteers of the University of Maastricht.
Key exclusion criteria (2 listed)
- Patients with a history of eating disorder different than AN or a psychiatric history.
- Control group: no history of eating disorders or other psychiatric disabilities. Normal physical examination, ecg, laboratorium (blood cells, liver, kidneys)
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
Concentration of ghrelin in blood.
Time frame: 1 morning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- BackgroundBosse, T.; Delfos., M.F.; Jonker, C.M. & Treur, J. (2003). Reasoning about adaptive Dynamical Systems in the Analysis of eating Regulation Disorders. N.J. Mahwah. Proceedings of the 25th Annual Conference of the Cognitive Science Society. Lawrence Erlbaum Associates Inc.
- BackgroundBoth, F. & Delfos, M.F. (in preparation). The role of ghrelin in eating disorders, a review.
Related trials for Anorexia Nervosa
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder
Anorexia Nervosa
RecruitingObservational study
Exploratory Study of Sensory Profile and Coping Strategies in Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
Hepatic Cytolysis
Active, not recruiting
Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
Anorexia Nervosa
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.
Martine F Delfos, Dr principal investigator
PICOWO Utrecht
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 Maastricht University Medical Center at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 9 Jan 2018. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of ghrelin in blood. (time frame: 1 morning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825461, which also lists 2 linked publications.
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 9 Jan 2018.