UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of insulin secretion and insulin resistance using with glucose clamp techinique
Title of the study (Brief title)	A study of insulin secretion and insulin resistance using with glucose clamp techinique
Region	Japan

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

Objectives
Narrative objectives1	Precise evaluation of insulin secretion and insulin resistance in Japanese type 2 DM using with glucose clamp technique
Basic objectives2	Others
Basic objectives -Others	To clarify natural history of type 2 DM in Japanese
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	insulin secretion: first and second phase insulin secretion under hyperglycemic clamp insulin resitance: glucose infusion rate under hyperinsulinemic clamp
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Capable to be inserted cathter at three different site at both arm
Key exclusion criteria	Having insulin allergy or insulin antibody
Target sample size	90

Research contact person
Name of lead principal investigator	Kazuhiko Sakaguchi
Organization	Department of internal medicine, Kobe University Graduate School of medicine
Division name	Division of Diabetes, Netabolism and Endocrinology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5861
Email

Public contact
Name of contact person	Kazuhiko Sakaguchi
Organization	Department of internal medicine, Kobe University Graduate School of medicine
Division name	Division of Diabetes, Netabolism and Endocrinology
Address
TEL
Homepage URL
Email	kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute	Divison of Diabetes, metabolism and Endcrinology Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	entrasted accounting money
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	2009 Year 09 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 09 Month 15 Day
Anticipated trial start date	2009 Year 09 Month 16 Day
Last follow-up date	2012 Year 03 Month 01 Day
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	Using with glucose clamp technique, insulin secretion capacity and insulin resistance should be measured precisely in 50 Type 2 DMs, 20 IGTs and 20 healthy volunteers

Management information
Registered date	2009 Year 08 Month 20 Day
Last modified on	2017 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002897