UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000579 |
|---|---|
| Receipt number | R000000704 |
| Scientific Title | A psychosomatic study for the functions of ghrelin. |
| Date of disclosure of the study information | 2010/03/31 |
| Last modified on | 2012/02/17 13:25:35 |
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Basic information
Public title
A psychosomatic study for the functions of ghrelin.
Acronym
A psychosomatic study for the functions of ghrelin.
Scientific Title
A psychosomatic study for the functions of ghrelin.
Scientific Title:Acronym
A psychosomatic study for the functions of ghrelin.
Region
| Japan |
Condition
Condition
Eating disorder
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between feeding regulatory peptides and eating behaviours, psychological states and clinical courses in patients with eating disorder for elucidate the pathophysiology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
feeding regulatory peptides(e.g.,ghrelin),
eating behaviour, nutritional change
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Subjects for patient group are patients with eating disorder. Inpatients are participated from admission to six months after discharge and outpatients are participated for six months after first oral glucose tolerance test. The treatment consists of behavioral therapy, nutritional rehabilitation and medication.
Oral glucose tolerance test is administered before treatment, during treatment and after treatment.
Interventions/Control_2
Subjects for control group are healthy volunteers. Oral glucose tolerance test is administered.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Subjects for patient group are patients with eating disorder. Each clinical disorder is diagnosed on the basis of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition.
Key exclusion criteria
The subjects are excluded if they had a history of alcohol abuse, substance abuse,
gastrointestinal disease, diabetes mellitus or other metabolic diseases.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Inui |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Behavioral Medicine
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima-City 890-8520, Japan
TEL
099-275-5751
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Behavioral Medicine
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima-City 890-8520, Japan
TEL
099-275-5751
Homepage URL
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
the Japanese Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2001 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 01 | Month | 23 | Day |
Last modified on
| 2012 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000704
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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