UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation with Muscle Mass / Fat Mass by Body Composition Analysis and Liver Fat Accumulation in Patients with Type 2 Diabetes Mellitus.
Title of the study (Brief title)	Correlation with Body Composition and Liver Fat Accumulation.
Region	Japan

Condition
Condition	Type 2 Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine correlation with Muscle Mass / Fat Mass by Body Composition Analysis and Liver Fat Accumulation in Japanese Type 2 DM.
Basic objectives2	Others
Basic objectives -Others	To examine correlation with blood tests and Liver Fat Accumulation in Japanese Type 2 DM.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Liver Fat Accumulation
Key secondary outcomes	Mass / Fat Mass by Body Composition Analysis

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Untreated type 2 DM
Key exclusion criteria	The patient who is treating liver disease. Unstable clinical conductions active, liver desease, cancer
Target sample size	120

Research contact person
Name of lead principal investigator	Noboru Kurinami
Organization	Jinnouchi Hospital
Division name	Diabetes Care Center
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL	096-363-0011
Email	kurinami@jinnouchi.or.jp

Public contact
Name of contact person	Noboru Kurinami
Organization	Jinnouchi Hospital
Division name	Diabetes Care Center
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL	096-363-0011
Homepage URL
Email	kurinami@jinnouchi.or.jp

Sponsor
Institute	Jinnouchi Hospital
Institute
Department

Funding Source
Organization	Jinnouchi Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	陣内病院（熊本）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
Anticipated trial start date	2018 Year 04 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	All patients with untreated T2DM who visited the Diabetes Care Center of Jinnouchi Hospital between June 2014 and March 2017

Management information
Registered date	2017 Year 10 Month 13 Day
Last modified on	2017 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033758