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

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 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

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

Value
https://center6.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