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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040489
Receipt No. 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

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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
Email 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
Email kiyokazu@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046166

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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