UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006858 |
|---|---|
| Receipt number | R000008099 |
| Scientific Title | Recearch for the role of the action of GLP-1 on normal glucose tolerance |
| Date of disclosure of the study information | 2011/12/07 |
| Last modified on | 2019/12/10 12:18:39 |
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Basic information
Public title
Recearch for the role of the action of GLP-1 on normal glucose tolerance
Acronym
Recearch for the role of the action of GLP-1 on normal glucose tolerance
Scientific Title
Recearch for the role of the action of GLP-1 on normal glucose tolerance
Scientific Title:Acronym
Recearch for the role of the action of GLP-1 on normal glucose tolerance
Region
| Japan |
Condition
Condition
Normal glucose tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of incretin related drugs for type 2 diabetes is widely noticed.Glucose dependent insulin secretion,glucose dependent glucagon suppression,inhibiton of gastrointestinal motility and protective effects for pancreatic B cell are well-known as the effects of incretin.However,on the human beings, it is not acceptable that how affect the many sided incretin action.Uncovering the incretin action on human is very important for determine that we should choice what kinds of incretin related drugs and use for what kinds of condition.
On the otherhand,the condition of type 2 diabetes is heterogeneity and it is not suitable for research of physiological incretin action,so we should evaluate the incretin effects in consideration of the ability of insulin secretion and insulin resistance.
Therefor,we research the role of incretin action on normal glucose tolerance that have relatively homogenous ability of insulin secretion and insulin resistance.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum blood glucose,insulin,CPR,gulucagon which are obtain from OGTT
Time:0,5,10,15,30,60,90,120,150,180 min
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
[exenatide]
subcutaneous injection of exenatide 5 ug, 30 min before 75gOGTT.
[liraglutide]
subcutaneous injection ofliraglutide 0.9 mg, 10hr before 75gOGTT.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal glucose torerance
Key exclusion criteria
ad lib blood glucose >= 200 mg/dl
hypersensitivity for the drugs
pregnancy or the possibility
HbA1c >= 6.1%
severe renal dysfunction and liver function
Considering unsuitable for this research with other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Enocrinology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5861
hirota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Enocrinology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5861
Homepage URL
hirota@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Diabetes and Enocrinology
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Trust Acounts of medical office
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
kobe University kainyu Kenkyu
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel
078-382-6669
kainyu@med.kobe-u.ac.jp
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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs12020-018-1808-9
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs12020-018-1808-9
Number of participants that the trial has enrolled
14
Results
Exenatide, but not liraglutide, markedly decelerated the peak of both plasma glucose and serum insulin levels during the OGTT, with the peaks of both glucose and insulin concentrations occurring at 150？min after test initiation with exenatide compared with 30？min in the control condition or with liraglutide. Exenatide and liraglutide reduced the area under the curve for plasma glucose levels during the OGTT by similar extents, whereas that for serum insulin levels was reduced only by exenatide.
Results date posted
| 2019 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 08 | Day |
Baseline Characteristics
Normal glucose tolerance
Participant flow
We recruited volunteers.
Adverse events
None.
Outcome measures
Differences between three OGTTs, which were performed without pharmacological intervention or after a single administration of exenatide or liraglutide at 30 min and 10 h, respectively, before test initiation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 07 | Day |
Last modified on
| 2019 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008099
