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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032223
Receipt No. R000036747
Scientific Title A pilot study examining the effects of intrahepatic glycogen content on the liver volume
Date of disclosure of the study information 2018/04/12
Last modified on 2019/04/18

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Basic information
Public title A pilot study examining the effects of intrahepatic glycogen content on the liver volume
Acronym A pilot study examining the effects of intrahepatic glycogen content on the liver volume
Scientific Title A pilot study examining the effects of intrahepatic glycogen content on the liver volume
Scientific Title:Acronym A pilot study examining the effects of intrahepatic glycogen content on the liver volume
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the relationship among intrahepatic glycogen, intrahepatic fat content, and liver volume by magnetic resonance spectrography.
Basic objectives2 Others
Basic objectives -Others To test physiological meanings
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship among intrahepatic glycogen, intrahepatic fat content, and liver volume by magnetic resonance spectrography.
Key secondary outcomes Relationship among intrahepatic glycogen, MRE score, portal vein flow

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Someone who can be informed consent.
2) Someone who has no apparent disease with any medication.
Key exclusion criteria 1) Claustrophobia
2) Contraindication for MRI/MRS
3) HbA1c >= 6.5 %
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Maegawa
Organization Shiga University of Medical Science
Division name Department of Medicine, Division of Endocrinology and Metabolism
Zip code 520-2192
Address Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
TEL 077-548-2222
Email maegawa@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Katsutaro
Middle name
Last name Morno
Organization Shiga University of Medical Science
Division name Shiga University of Medical Science Department of Medicine, Division of Endocrinology and Metabolism
Zip code 520-2192
Address Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
TEL 077-548-2222
Homepage URL
Email morino@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Department of Medicine, Division of Endocrinology and Metabolism
Institute
Department

Funding Source
Organization Shiga University of Medical Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiga University of Medical Science
Address Tsukinowa Seta Otsu
Tel +81-77-548-3576
Email hqrec@belle.shiga-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 滋賀医科大学

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 12 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
2018 Year 08 Month 21 Day
Date of IRB
2018 Year 06 Month 15 Day
Anticipated trial start date
2018 Year 09 Month 18 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information MRE value, ADC value, blood glucose, insulin, glucagon, T-Cho, TG, HDL, LDL, FFA. Glycerol, visceral fat area, subcutaneous fat area, weight, height, portal vein blood flow

Management information
Registered date
2018 Year 04 Month 12 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036747

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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