Anorexia NervosaNCT00631605
Studies of Neuroendocrine and Energy Metabolism in Patients With Eating Disorders
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism in patients with eating disorder and their relationships with psychopathology of eating disorders (eating patterns, depression, and personality) in these patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2007to Jan 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with eating disorders and normal controls
Who may be able to join
- Subjects who fulfilled DSM-IV diagnosis of anorexia nervosa or bulimia nervosa
- Normal controls
Who cannot join
- Any major psychiatric disorders
- Use of psychoactive medications
- Drug and alcohol abuse
- Medical problems (cardiovascular condition and endocrine disorders)
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism in patients with eating disorder and their relationships with psychopathology of eating disorders (eating patterns, depression, and personality) in these patients.
Read the detailed description
The study subjects include female patients with DSM-IV diagnosis of AN (n = 30), BN (n = 60) and age-controled normal subjects (n = 30). They will receive a clinical interview and are asked to complete several self-administered questionnaires which included eating-related questionnaires, general psychological functioning scales and personality scales. After overnight fast, each subject undergoes a blood sample collection for neuroendocrine examination, body composition examination using BIA method, basal metabolic rate measurement by indirect calorimetry, and ECG in the morning between 0800 and 0900. Clinical patients would be asked to repeat filling the self-rating scales, weight and body fat measurement, as well as blood drawing again 2 months after treatment.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Keywords
- eating disorders, ghrelin, leptin, BIA
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Feeding and Eating Disorders
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 | Not described | |
| 2 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2009
- Study completionJan 2009
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 National Taiwan University HospitalThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Chih Tseng, MD, Msc, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631605
- Sponsor's protocol ID
- 200705061R
- Status last verified
- Mar 2009
- First submitted
- 3 Mar 2008
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Neuroendocrine and Energy Metabolism in Patients With Eating Disorders
- ClinicalTrials.gov ID
- NCT00631605
- Acronym / sponsor ID
- 200705061R
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Keywords
- eating disorders, ghrelin, leptin, BIA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Mar 2008 (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.
This study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism in patients with eating disorder and their relationships with psychopathology of eating disorders (eating patterns, depression, and personality) in these patients.
Detailed description
The study subjects include female patients with DSM-IV diagnosis of AN (n = 30), BN (n = 60) and age-controled normal subjects (n = 30). They will receive a clinical interview and are asked to complete several self-administered questionnaires which included eating-related questionnaires, general psychological functioning scales and personality scales. After overnight fast, each subject undergoes a blood sample collection for neuroendocrine examination, body composition examination using BIA method, basal metabolic rate measurement by indirect calorimetry, and ECG in the morning between 0800 and 0900. Clinical patients would be asked to repeat filling the self-rating scales, weight and body fat measurement, as well as blood drawing again 2 months after treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with eating disorders and normal controls
Key inclusion criteria (2 listed)
- Subjects who fulfilled DSM-IV diagnosis of anorexia nervosa or bulimia nervosa
- Normal controls
Key exclusion criteria (4 listed)
- Any major psychiatric disorders
- Use of psychoactive medications
- Drug and alcohol abuse
- Medical problems (cardiovascular condition and endocrine disorders)
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
Not reported in the source record.
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 3 Mar 2009.
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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.
Mei-Chih Tseng, MD, Msc principal investigator
National Taiwan University Hospital
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 and Bulimia Nervosa, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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 3 Mar 2009. 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 Taiwan. 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.
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 3 Mar 2009.