UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The assessment of endogenous glucose production and insulin-stimulated glucose disposal in type 2 diabetes patients using a euglycemic insulin clamp technique with [6,6-2D2]glucose infusion, non-randomized intergroup trial
Title of the study (Brief title)	Endogenous glucose production and insulin-stimulated glucose disposal in type 2 diabetes patients.
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess organ-specific insulin resistance in the liver (endogenous glucose production) and skeletal muscle (insulin-stimulated glucose disposal) in Japanese type 2 diabetes patients using a euglycemic insulin clamp technique with [6,6-2D2]glucose infusion.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Endogenous glucose production and insulin-stimulated glucose disposal.
Key secondary outcomes	1) Suppression of endogenous glucose production by insulin. 2) Plasma glucose, plasma insulin, C-peptide and free fatty acid. 3) The association of fasting plasma glucose, HbA1c, HOMA-IR, HOMA-beta, CPI, hepatic function, blood-cholesterol level and hematological value with endogenous glucose production and insulin-stimulated glucose disposal. 4) Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Until March 31, 2018.Type 2 diabetes patients with fatty liver and obesity undergo a euglycemic insulin clamp technique once.
Interventions/Control_2	Until March 31, 2018. Type 2 diabetes patients without fatty liver and obesity undergo a euglycemic insulin clamp technique once.
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	1) Hospitalized type 2 diabetes patients. 2) Age is over 20 years and less than 80 years. 3) Patients who can undergo euglycemic insulin clamp technique within seven days of admission. 4) Patients with CAP(controlled attention parameter) > 232.5 dB/m and BMI(body mass index) > 25 kg/m2, or with CAP < 232.5 dB/m and BMI < 25 kg/m2. 5) Patients who obtained document agreement by free will of themselves on understanding after enough explanation when participating about examination is received.
Key exclusion criteria	1) Patients with known bleeding disorders. 2) Type 1 diabetes and secondary diabetes patients. 3) Patients with severe renal disease(s-Cre > 2.0 mg/dl). 4) Patients with severe liver disease (AST or ALT > 100 IU/L). 5) Patients who are unable to be responsible for informed consent due to severe psychiatric disease. 6) Excessive common custom drinker (alcohol > 100 ml/day). 7) Patients who have a history of hypersensitivity. 8) Pregnant or possibly pregnant women. 9) Women on lactation. 10) In addition, patients who were judged inappropriate by an attendant physician.
Target sample size	10

Research contact person
Name of lead principal investigator	Naoto kubota
Organization	Tokyo University
Division name	Department of Diabetes and Endocrinology
Address	7-3-1 Hongo, Bunkyouku, Tokyo, Japan
TEL	03-3815-5411
Email	nkubota-tky@umin.org

Public contact
Name of contact person	Ai Morita
Organization	Tokyo University
Division name	Department of Diabetes and Endocrinology
Address	7-3-1 Hongo, Bunkyouku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	imo33edo@gmail.com

Sponsor
Institute	Tokyo University faculty of Medicine Department of Diabetes and Endocrinology
Institute
Department

Funding Source
Organization	Tokyo University faculty of Medicine
Organization
Division
Category of Funding Organization	Other
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	2015 Year 01 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 08 Day
Anticipated trial start date	2015 Year 01 Month 19 Day
Last follow-up date	2018 Year 06 Month 25 Day
Date of closure to data entry	2018 Year 06 Month 25 Day
Date trial data considered complete	2018 Year 10 Month 04 Day
Date analysis concluded	2018 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 19 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018867