UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of weight loss effect of diabetes treatment for obese type 2 diabetic patients.
Title of the study (Brief title)	Comparison of weight loss effect of diabetes treatment for obese type 2 diabetic patients.
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By bariatric surgery on obese type 2 diabetic patients, not only weight loss effect but also metabolic improvement effect can be expected. However, bariatric surgery, which is applied for insurance in Japan, is only sleeve gastrectomy. Patients with obesity, which is an indication for surgery, are, in principle, patients with primary obesity between the ages of 18 and 65, and there is no significant weight loss and no improvement in obesity related complications despite medical treatments for more than 6 months. Until recently, although diabetes treatment have an effect of improving blood glucose, body weight gain accompanying treatment became a problem. GLP-1 receptor agonist and SGLT2 inhibitor are on the market. I evaluated the effect of GLP-1 receptor agonist and SGLT-2 inhibitor on obese type 2 diabetic patients on the parameters of blood glucose and BMI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c(0M,6M)
Key secondary outcomes	BMI(0M,6M)

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	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group treated with GLP-1 receptor agonist(Duration:6 months)
Interventions/Control_2	The group treated with SGLT-2 inhibitor(Duration:6 months)
Interventions/Control_3	The group treated with GLP-1 receptor agonist and SGLT-2 inhibitor(Duration:6 months)
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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	BMI>=22.0
Key exclusion criteria	Renal dysfunction(eGFR>=30mL/min/1.73m2)
Target sample size	60

Research contact person
Name of lead principal investigator	Takahisa Hasegawa
Organization	KYORITSU HOSPITAL
Division name	internal medicine
Address	16-5, Chuo-cho, Kawanishi-city,Hyogo
TEL	072-758-1131
Email	h.taka517@gmail.com

Public contact
Name of contact person	Takahisa Hasegawa
Organization	KYORITSU HOSPITAL
Division name	internal medicine
Address	16-5, Chuo-cho, Kawanishi-city,Hyogo
TEL	072-758-1131
Homepage URL
Email	h.taka517@gmail.com

Sponsor
Institute	KYORITSU HOSPITAL
Institute
Department

Funding Source
Organization	KYORITSU 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	協立病院

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 04 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	2017 Year 06 Month 20 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031871