UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the visceral fat and adipocytokine by SGLT2 inhibitors in type 2 diabetes millitus
Title of the study (Brief title)	Impact on the visceral fat and adipocytokine by SGLT2 inhibitors
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect on visceral fat and adipocytokine by SGLT2 inhibitors
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat Body composition Body weight Lipid Adipocytokine
Key secondary outcomes	HbA1c Fasting plasma glucose Serum Insulin Glycogen Serum ketone body Urinary glucose excretion Urinary albumin Blood pressure

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
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	Divide in the preceding administration group and the trailing administered group. Preceding administration group to medication the SGLT2 inhibitor for about 12 weeks. After that, this group to abort the SGLT2 inhibitor and observe for about 12 weeks. We prescribe only Dapagliflozin 5mg in this study.
Interventions/Control_2	Trailing administration group to observe for about 12 weeks in reverse order. We prescribe only Dapagliflozin 5mg in this study.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Men and women who were diagnosed with type 2 diabetes. Patients who are considered treatment with SGLT2 inhibitors is suitable. Patients who are obtained informed consent.
Key exclusion criteria	1.Type 1 diabetes, secondary diabetes 2.Severe ketosis, diabetic coma, or before coma 3.Severe infection, before and not long after surgery, or patients with severe trauma 4.Severe cerebrovascular dysfunction, heart disorder, renal dysfunction and liver dysfunction 5.Heart failure(NYHA classification 3-4), patients treated by diuretic 6.Patients who have repeated urinary tract infections 7.Alchole intake excessive 8.Women suspected of pregnancy or pregnant 9.Patients with a history of use SGLT2 inhibitors
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshimasa Aso
Organization	Dokkyo medical university
Division name	Endocrinology and Metabolism
Address	880 Kitakobashi, Mibu, Shimotsuga-gun,Tochigi,JAPAN
TEL	0282-86-1111
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Masaaki Sagara
Organization	Dokkyo medical university
Division name	Endocrinology and Metabolism
Address	880 Kitakobashi, Mibu, Shimotsuga-gun,Tochigi,JAPAN
TEL	0282-86-1111
Homepage URL
Email	sgrmsak@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo medical university, Endocrinology and Metabolism
Institute
Department

Funding Source
Organization	none
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 09 Month 01 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

Management information
Registered date	2016 Year 05 Month 31 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025981