UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Introduction of indices of clinical insulin resistance / sensitivity under significant urinary glucose excretion
Title of the study (Brief title)	indices of insulin sensitivity under using SGLT-2 inhibitors (ISUUSI)
Region	Japan

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

Objectives
Narrative objectives1	OGTT (oral glucose tolerance test) will be appled to subjects with type 2 dibetes mellitus who are using SGLT-2 inhibitors. The data obtained during OGTT is used to assess insulin sensitivity and insulin resistance.
Basic objectives2	Others
Basic objectives -Others	Urine excretion during OGTT change of HOMA-beta or insulinogenic index (if any)
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes of muscle insulin sensitivity and liver insulin resistance (should be consistant to the effect of SGLT-2 inhibitors, when compared with previous studies)
Key secondary outcomes	1)Exsitence of difference between the new indices and HOMA-IR or Matsuda index without considering urine glucose excretion 2)Consistence of beta cell function measured by HOMA-beta or insulinogenic inex 3)Any changes in the disposition index 4)Existance of urinary glucose excretion after terminatio of SGLT-2 inhibitors

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	Subjects should be type 2 diabetic patients who have stable glycemic control for more than 2 months, and their HbA1c should be less than 8.0 %. Subjects who are taking pioglitazone or metformin or DPP-4 inhibitors will be also enrolled.
Key exclusion criteria	1) Under the treatment with insulin 2) Type 1 diabetic subjects or diabetic subjects who have HbA1c more than or equal to 8.0 % or who need admission because of diabetic ketoacidosis or extreme hyperglycemia. 3) Subjects who are treated with sulfonylureas (i.e. glibenclamide, glimepiride, or gliclazide). 4) Subjects with nephrotic syndrome (urine protein more than or equal to 3.5g/day and serum protein less than or equal to 6.0 g/dl [or serum albumin less than or equal to 3.0 g/dl]. 5) Subjects who are taking steroids, immune suppression medication, antifungal medication of azoles. HIV protease inhibitors 6) Subjects who had brain stroke or acute coronary syndrome within 6 months before enrollment. 7) Subjects with severe heart failure (NYHA class 3 or higher), severe arrhythmia (frequent atrial or ventral arrhythmia, continuous ventricular tachycardia, severe atrial tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome or atrial-ventral block with severe bradycardia). 8) Subjects who have AST or ALT more than 5 times of upper normal limit of their institute 9) Subjects with malignancy 10) Subjects who are pregnant or who have intention to be pregnant 11) Subjects with other situations under which a doctor in charge decides that subjects are not eligible for this study.
Target sample size	20

Research contact person
Name of lead principal investigator	Masafumi Matsuda
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Endocrinology and Diabetes
Address	1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL	049-228-3564
Email	matsudam-ind@umin.ac.jp

Public contact
Name of contact person	Masafumi Matsuda
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Endocrinology and Diabetes
Address	1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL	049-228-3564
Homepage URL
Email	matsudam-ind@umin.ac.jp

Sponsor
Institute	Department of Endocrinology and Diabetes Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Department of Endocrinology and Diabetes Saitama Medical Center, Saitama Medical University
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	埼玉医科大学総合医療センター 内分泌・糖尿病内科

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 15 Day
Anticipated trial start date	2014 Year 07 Month 15 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	Insulin sensitivity will be examined by condcting OGTT before and after the use of an SGLT2 inhibitor. Due to the problem of assay of glucagon this study has not been initiated.

Management information
Registered date	2014 Year 06 Month 05 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016505