UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the secretion of glucagon for glucose intolerance
Title of the study (Brief title)	Investigation of the secretion of glucagon for glucose intolerance
Region	Japan

Condition
Condition	Normal glucose tolerance (NGT), Impaired glucose tolerance(IGT), Type 2 diabetes (T2DM)
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The response of glucagon wii be examined during the oral glucose tolelrance test and the hyperglycemic clamp in Japanease subjects with NGT, IGT and T2DM.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the area under the glucagon curve during hyperglycemic clamp among three groups (NGT,IGT and T2DM)
Key secondary outcomes	Comparison of the area under the insulin curve during hyperglycemic clamp among three groups (NGT,IGT and T2DM)

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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Capable to be inserted cathter at three different site at both arm 2)The level of fasting plasma glucose less than 130 mg/dl
Key exclusion criteria	1)Type 1 DM 2)Pancreatic diabetes 3)Medical history of gastrointestinal tract surgery 4)Having insulin antibody(>10%) 5)Treatment with any long-acting insulin 6)Treatment with steroid 7)Impaired liver function, defined as alanine aminotransferase >2 times upper limit of normal(HBC or HCV infection) 8) Impaired renal function defined as eGFR <60ml/min 9) Severe cardiac dysfunction (> NYHA 3) 10)Cancer and medical history of cancer 11)Pregnancy or breast feeding 12)Known or suspected abuse of alcohol, narcotics or illicit drugs 13)Mental retardation or dementia or other inappropriate persons judged by investigators
Target sample size	105

Research contact person
Name of lead principal investigator	Kazuhiko Sakaguchi
Organization	Kobe university school of medicine
Division name	Diabetes and Endocrinoplogy
Address	7-5-1,Kusunoki-Cho, Chuo-Ku, Kobe
TEL	078-382-5861
Email	kzhskskgc@med.kobe-u.ac.jp

Public contact
Name of contact person	Kazuhiko Sakaguchi
Organization	Kobe university school of medicine
Division name	Diabetes and Endocrinoplogy
Address	7-5-1,Kusunoki-Cho, Chuo-Ku, Kobe
TEL	078-382-5861
Homepage URL
Email	kzhskskgc@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university school of medicine, Diabetes and Endocrinoplogy
Institute
Department

Funding Source
Organization	Donation
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 11 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 10 Month 06 Day
Anticipated trial start date	2015 Year 11 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	none

Management information
Registered date	2015 Year 10 Month 06 Day
Last modified on	2018 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019812