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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020923
Receipt No. R000024106
Scientific Title Effect of the SGLT2 inhibitor on basal energy expenditure in type 2 diabates mellitus
Date of disclosure of the study information 2016/02/08
Last modified on 2018/08/12

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Basic information
Public title Effect of the SGLT2 inhibitor on basal energy expenditure in type 2 diabates mellitus
Acronym SGLT2 inhibitor intervention study
Scientific Title Effect of the SGLT2 inhibitor on basal energy expenditure in type 2 diabates mellitus
Scientific Title:Acronym SGLT2 inhibitor intervention study
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the influence of SGLT2 inhibitor on resting energy expenditure in type 2 diabetes mellitus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes resting energy expenditure of three months after taking medicine
Key secondary outcomes body weight, respiration quotient and HbA1c of three months after taking medicine

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patient takes medicine with SGLT2 inhibitor of three months.
We prescribe only Empagliflozin in this study.
The dosage depends on therapy.
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
30 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria patients with type 2 diabetes mellitus
Key exclusion criteria A patient with much active mass (exercise) in everyday life
A patient with after the third diabetic nephropathy
A patient with liver function abnormality
85 years or older
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eitaro Nakashima
Organization Chubu Rosai Hospital, Japan Labour Health and Welfare Organization
Division name DiaDiabetes & Endocrinology, Diabetes Center
Zip code
Address 1-10-6 Koumei Minato-ku Nagoya
TEL 052-652-5511
Email eitaro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eitaro Nakashima
Organization Chubu Rosai Hospital, Japan Labour Health and Welfare Organization
Division name DiaDiabetes & Endocrinology, Diabetes Center
Zip code
Address 1-10-6 Koumei Minato-ku Nagoya
TEL 052-652-5511
Homepage URL
Email eitaro@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University of Arts and Sciences
Institute
Department

Funding Source
Organization Nagoya University of Arts and Sciences
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 08 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
REE showed a decreasing trend of 1554(SD257)kcal/day and 1491(SD313)kcal/day before and after administration of SGLT 2 inhibitor, respectively, but it was not significant.
In addition, there was no significant difference in REE per body weight. Body weight and body fat mass decreased significantly, but skeletal muscle mass did not change significantly.
In conclusion, it was suggested that taking SGLT 2 inhibitor for 3 months may not affect REE.
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
2016 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 25 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 20 Day
Date analysis concluded
2018 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 08 Day
Last modified on
2018 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024106

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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