UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019252
Receipt number R000019812
Scientific Title Investigation of the secretion of glucagon for glucose intolerance
Date of disclosure of the study information 2015/11/01
Last modified on 2018/10/08 19:10:41

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Basic information

Public title

Investigation of the secretion of glucagon for glucose intolerance

Acronym

Investigation of the secretion of glucagon for glucose intolerance

Scientific Title

Investigation of the secretion of glucagon for glucose intolerance

Scientific Title:Acronym

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

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Kobe university school of medicine

Division name

Diabetes and Endocrinoplogy

Zip code


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

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Kobe university school of medicine

Division name

Diabetes and Endocrinoplogy

Zip code


Address

7-5-1,Kusunoki-Cho, Chuo-Ku, Kobe

TEL

078-382-5861

Homepage URL


Email

kzhskskgc@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe university school of medicine, Diabetes and Endocrinoplogy

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2015 Year 10 Month 06 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019812


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name