UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects on the improvement of blood glucose and changes in body composition of oral anti-diabetic drug SGLT2 inhibitor.~ Relevance to the compliance of the diet therapy for diabetes~
Title of the study (Brief title)	Effect of SGLT2 inhibitor and diet therapy
Region	Japan

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

Objectives
Narrative objectives1	The SGLT2 inhibitor which is an oral medicine for diabetes exerts the blood glucose lowering effect by promoting urinary glucose excretion. The aim of this study is to clarify the effect of the improvement of blood glucose levels, the influence for the changing of body composition including body weight and muscle weight. In addition, we focus on the adherence to the diet therapy for diabetes, and determine the factors of the difference of the showing effect of SGLT2 inhibitor in the patients who show the effectiveness or non-effectiveness.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of Parameters of blood glucose (HbA1c, fasting blood glucose, glycoalbumin, insulin,CPR)
Key secondary outcomes	1)Amount of change in Body weight 2)Amount of change in Body composition (fat, muscle etc.) 3)Carbohydrate intake 4)Urinary albumin excretion 5)eGFRcreat (calculation by conversion formula of GFRcreat in Japanese), serum creatinine 6)Urinary L-FABP excretion, serum cystatinC (Cys-C), eGFRcys (calculation by conversion formula of eGFRcys in Japanese) 7)Serum lipid (T-cho, LDL, HDL, TG) 8)Blood pressure, pulse 9)Liver function(AST,ALT,gammaGTP) 10)Uric acid 11)Hematocrit 12)Ketone Body,Lactic acid 13)BDHQ: intake of energy, protein, lipid and dietary fiber, nutritional education

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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Outpatients and hospitalized patients in the department of endocrinology and metabolism of Kanazawa Medical University Hospital. The diabetic patiens who have the adaptation for the treatment of SGLT2 inhibitor that was judged by the physician (>=20 and<=80 of age)
Key exclusion criteria	None
Target sample size	30

Research contact person
Name of lead principal investigator	Daisuke Koya
Organization	Kanazawa Medical University
Division name	Diabetology and Endocrinology
Address	1-1Daigaku,Uchinada,Kahoku-gun, Ishikawa Prefecture, 920-0293
TEL	076-286-2211
Email	koya0516@kanazawa-med.ac.jp

Public contact
Name of contact person	Yuka Kuroshima
Organization	Kanazawa Medical University
Division name	Diabetology and Endocrinology
Address	1-1Daigaku,Uchinada,Kahoku-gun, Ishikawa Prefecture, 920-0293
TEL	076-286-2211
Homepage URL
Email	naipicrc@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
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 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 20 Day
Anticipated trial start date	2015 Year 06 Month 02 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	Published
URL releasing results
Results
Other related information	We clarify the effect of the improvement of blood glucose levels, the influence for the changing of body composition including body weight and muscle weight. In addition, we focus on the adherence to the diet therapy for diabetes, and determine the factors of the difference of the showing effect of SGLT2 inhibitor in the patients who show the effectiveness or non-effectiveness.

Management information
Registered date	2016 Year 06 Month 14 Day
Last modified on	2018 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026181