UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040489 |
|---|---|
| Receipt number | R000046166 |
| Scientific Title | Relationship between brain glucose metabolism and default mode network during the course of recovery in anorexia nervosa: PET/MRI multi-modal study. |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/05/22 13:16:21 |
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Basic information
Public title
Relationship between brain glucose metabolism and function during the course of recovery in anorexia nervosa
Acronym
Relationship between brain glucose metabolism and function during the course of recovery in anorexia nervosa
Scientific Title
Relationship between brain glucose metabolism and default mode network during the course of recovery in anorexia nervosa: PET/MRI multi-modal study.
Scientific Title:Acronym
Relationship between brain glucose metabolism and default mode network during the course of recovery in anorexia nervosa: PET/MRI multi-modal study.
Region
| Japan |
Condition
Condition
Anorexia neruvosa
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate brain glucose metabolism and functional connectivity during the course of recovery in anorexia nervosa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
functional connectivity between brain regions
Key secondary outcomes
brain glucose metabolism
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
PET/MRI
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1.female aged between 18 and 40
2.a person who agrees with written consent or proxy consent of this research
<patients>
a person who receives inpatient treatment for anorexia nervosa
<healthy comparisons>
BMI between 18 and 25
Key exclusion criteria
1. the presence of space occupying lesion or vascular abnormalities in the brain
2. a history of neurological or psychiatric disorders
3. contraindications for an PET Scan
4. contraindications for an MRI Scan
5. pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | TAKEBAYASHI |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry and Neurology
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL
0534352295
kiyokazu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kiyokazu |
| Middle name | |
| Last name | TAKEBAYASHI |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry and Neurology
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL
0534352295
Homepage URL
kiyokazu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
Tel
053-435-2680
rinri@hama-med.ac.jp
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
| 2020 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 22 | Day |
Last modified on
| 2020 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046166
