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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029205
Receipt No. R000033385
Scientific Title Effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition in Japanese Type 2 Diabetes Patients without severe Obesity
Date of disclosure of the study information 2017/12/31
Last modified on 2018/09/26

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Basic information
Public title Effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition in Japanese Type 2 Diabetes Patients without severe Obesity
Acronym Effects of Dapagliflozin on Body Composition
Scientific Title Effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition in Japanese Type 2 Diabetes Patients without severe Obesity
Scientific Title:Acronym Effects of Dapagliflozin on Body Composition
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 effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition including Fat, muscle, and water, in Japanese Type 2 DM
Basic objectives2 Others
Basic objectives -Others To examine effects of Dapagliflozin, a SGLT2 inhibitor, on Endothelial Function in Japanese Type 2 DM
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change in Skeletal Muscle Mass
Key secondary outcomes Changes in Fat mass, water volume, endothelial function, liver fat content, and kidney function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dapagliflozin; 5mg/day
Interventions/Control_2 non-SGLT2 inhibitor treatment for DM
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
80 years-old >
Gender Male and Female
Key inclusion criteria Type 2 DM
HbA1c>7.0%
no history of SGLT2 inhibitor-treatment
patients with on-going diet and exercise therapies
Key exclusion criteria severe obesity (BMI>35)
Type 1 DM
ketoacidosis
unstable clinical conditions
active infection, liver disease, cancer
eGFR<45
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seigo Sugiyama
Organization Jinnouchi Hospital
Division name Diabetes Care Center
Zip code
Address 6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL 096-363-0011
Email seigosugiyama@jinnouchi.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seigo Sugiyama
Organization Jinnouchi Hospital
Division name Diabetes Care Center
Zip code
Address 6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL 096-363-0011
Homepage URL
Email seigosugiyama@jinnouchi.or.jp

Sponsor
Institute Jinnouchi Hispital
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 (熊本県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/jat/25/6/25_40873/_article
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 Completed
Date of protocol fixation
2014 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 09 Month 25 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2018 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033385

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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