UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031697 |
|---|---|
| Receipt number | R000036201 |
| Scientific Title | A retrospective study on beta cell function in type 2 diabetic patients using GLP-1 receptor agonist |
| Date of disclosure of the study information | 2018/03/25 |
| Last modified on | 2018/03/13 10:05:25 |
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Basic information
Public title
A retrospective study on beta cell function in type 2 diabetic patients using GLP-1 receptor agonist
Acronym
A retrospective study on beta cell function in type 2 diabetic patients using GLP-1 receptor agonist
Scientific Title
A retrospective study on beta cell function in type 2 diabetic patients using GLP-1 receptor agonist
Scientific Title:Acronym
A retrospective study on beta cell function in type 2 diabetic patients using GLP-1 receptor agonist
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy on beta cell functions in long-term-GLP-1 use
Basic objectives2
Others
Basic objectives -Others
To compare the effect of a GLP-1RA or DPP-4is
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum CPR level with glucagon challenge test
Key secondary outcomes
HbA1c level, Body weight
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
( a ) Beta cell function was assessed with Glucagon challenge test ( GCT ) which is using 1mg intravenous glucagon injection.
( b ) DPP4is or liraglutide was administrated for 5years.
( c ) 5 years after administration of DPP-is or liraglutide, beta cell function was re-assessed using GCT.
Key exclusion criteria
type 1 diabetes, an estimated glomerular filtration rate (eGFR) < 30ml/min, liver cirrhosis, steroid or any hyperglycemic drugs use and malignant desease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamamoto |
Organization
Showa University of medicine
Division name
the department of internal medicine, the division of diabetology, metabolism and endocrinology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8947
tak3105@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamamoto |
Organization
Showa University of medicine
Division name
the department of internal medicine, the division of diabetology, metabolism and endocrinology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8947
Homepage URL
tak3105@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University of medicine, the department of internal medicine, the division of diabetology, metabolism and endocrinology
Institute
Department
Personal name
Funding Source
Organization
none
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
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | 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
This study is retrospective cohort study analyzed data from the medical records of T2D patients treated with DPP-4is or liraglutide for 5 years. Those patients visited to Showa University Hospital between June 2010 and September 2017. The glucagon chellenge
test was carried out before and 5 years after treatment.
Management information
Registered date
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2018 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036201
