Anorexia NervosaNCT00602264
Adipokines and Ghrelin Concentrations in Different Stages of Anorexia Nervosa
An observational study of Anorexia Nervosa and Adipokines, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters. Read more about this study
- Who is it for?
- Ages 16 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Adipokines
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2006to May 2007
- 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 16 to 32 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with anorexia nervosa and constitutionally thin healthy subjects
Who may be able to join
- Diagnosis of anorexia nervosa for Group 1-3
- Constitutionally thin healthy subjects for Group 4
Who cannot join
- Medical or psychiatric diagnosis other than anorexia nervosa,
- History of gastrointestinal disease for Group 1-3
- History of eating disorder or gastrointestinal or psychiatric disease for control group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Univetsity, Istanbul Medical Faculty, Department of Psychiatrics
Istanbul
About this study
Official title: Adipocytokine and Ghrelin Concentrations in Different Stages of Anorexia Nervosa
The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.
Read the detailed description
Objective: The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.
Design: The study group is composed of four groups. Group1: Treatment-naïve patients with a recent diagnosis of AN (n:19), Group 2: The weight recovered (10 % increase in body weight compared with baseline weight) subgroup of group 1 at the end of a mean 117.72±98.14 days of follow-up (n: 12), Group 3: Recovered patients with a previous history of AN but normal menstrual cycles and body weight at the present time (n:10), Group 4: Control group: constitutionally thin healthy young women with normal menstrual cycles (n:10). Venous blood was obtained for measurements of biochemical parameters, ApN, leptin and ghrelin and body composition was determined by bioimpedance analysis.
- Conditions
- Anorexia Nervosa, Adipokines
- Keywords
- Anorexia nervosa, Adipokines, Ghrelin, Fat mass
- 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 | Treatment-naïve patients with a recent diagnosis of anorexia nervosa | |
| 2 | The weight recovered subgroup of group 1 | |
| 3 | Recovered patients with a previous history of anorexia nervosa but normal menstrual cycles and body weight at the present time | |
| 4 | Control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startFeb 2006
- Study completionMay 2007
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 Istanbul UniversityThe 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
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Investigators
- Ayse Kubat Uzum, M.D, Study director, Istanbul University Istanbul Medical Faculty Department of Endocrinology and MetabolismBasak Yucel, Professor, Principal investigator, Istanbul University Istanbul Medical Faculty Department of PsychiatricsBeyhan Omer, Professor, Study chair, Istanbul University Istanbul Medical Faculty Department of BiochemistryNese Colak Ozbey, Professor, Study director, Istanbul University Istanbul Medical Faculty Department of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602264
- Sponsor's protocol ID
- 503/5052006
- Other IDs
- 2005/1795
- Status last verified
- Jan 2008
- First submitted
- 15 Jan 2008
- Last updated
- 28 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipocytokine and Ghrelin Concentrations in Different Stages of Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00602264
- Acronym / sponsor ID
- 503/5052006
- Conditions
- Anorexia Nervosa, Adipokines
- Keywords
- Anorexia nervosa, Adipokines, Ghrelin, Fat mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- May 2007 (actual)
- First posted
- 28 Jan 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.
The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.
Detailed description
Objective: The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.
Design: The study group is composed of four groups. Group1: Treatment-naïve patients with a recent diagnosis of AN (n:19), Group 2: The weight recovered (10 % increase in body weight compared with baseline weight) subgroup of group 1 at the end of a mean 117.72±98.14 days of follow-up (n: 12), Group 3: Recovered patients with a previous history of AN but normal menstrual cycles and body weight at the present time (n:10), Group 4: Control group: constitutionally thin healthy young women with normal menstrual cycles (n:10). Venous blood was obtained for measurements of biochemical parameters, ApN, leptin and ghrelin and body composition was determined by bioimpedance analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Treatment-naïve patients with a recent diagnosis of anorexia nervosa |
| 2 | – | –The weight recovered subgroup of group 1 |
| 3 | – | –Recovered patients with a previous history of anorexia nervosa but normal menstrual cycles and body weight at the present time |
| 4 | – | –Control group |
Who may qualify
- Ages
- 16 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with anorexia nervosa and constitutionally thin healthy subjects
Key inclusion criteria (2 listed)
- Diagnosis of anorexia nervosa for Group 1-3
- Constitutionally thin healthy subjects for Group 4
Key exclusion criteria (3 listed)
- Medical or psychiatric diagnosis other than anorexia nervosa,
- History of gastrointestinal disease for Group 1-3
- History of eating disorder or gastrointestinal or psychiatric disease for control group
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 28 Jan 2008.
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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.
Ayse Kubat Uzum, M.D study director
Istanbul University Istanbul Medical Faculty Department of Endocrinology and Metabolism
Basak Yucel, Professor principal investigator
Istanbul University Istanbul Medical Faculty Department of Psychiatrics
Beyhan Omer, Professor study chair
Istanbul University Istanbul Medical Faculty Department of Biochemistry
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 Adipokines, run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 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 28 Jan 2008. 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 Turkey (Türkiye). 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 28 Jan 2008.