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
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
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
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
