UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024556 |
|---|---|
| Receipt number | R000028260 |
| Scientific Title | Effect on GLP-1 receptor expression in human artery with Type2 diabetes |
| Date of disclosure of the study information | 2016/10/25 |
| Last modified on | 2016/10/25 10:27:40 |
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Basic information
Public title
Effect on GLP-1 receptor expression in human artery with Type2 diabetes
Acronym
Effect on GLP-1 receptor expression in human artery with Type2 diabetes
Scientific Title
Effect on GLP-1 receptor expression in human artery with Type2 diabetes
Scientific Title:Acronym
Effect on GLP-1 receptor expression in human artery with Type2 diabetes
Region
| Japan |
Condition
Condition
More than 20-year-old patient who carry out an arterial operation
Classification by specialty
| Endocrinology and Metabolism | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the alteration of vascular GLP-1 receptor expression and the factors affecting its expression in human artery.
Basic objectives2
Others
Basic objectives -Others
Observational study using the artery of the patient performing an artery operation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GLP-1 receptor expressions of vascular endothelial cells and smooth muscle cells
Key secondary outcomes
Sex, Past history, Family history of diabetes, Oral medicine, Blood pressure, BMI, HbA1c, Blood glucose, Insulin, Lipid
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
More than 20-year-old patient who carry out an arterial operation
Key exclusion criteria
Patients with endocrine disorders and severe mental disorder.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Kimura |
Organization
Kawasaki Medical School
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
Matsushima 577, Kurashiki, Okayama, Japan
TEL
086-462-1111
tomohiko@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Kimura |
Organization
Kawasaki Medical School
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
Matsushima 577, Kurashiki, Okayama, Japan
TEL
086-462-1111
Homepage URL
tomohiko@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
YES
Study ID_1
1933
Org. issuing International ID_1
Kawasaki Medical School ethics committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | 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
GLP-1 receptor gene expression in human artery was down-regulated in subjects with obesity.
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 21 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 21 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 21 | Day |
Other
Other related information
40 cases were registered, genetic analysis and immunostaining were performed, GLP-1 receptor expressions in intima and media were down-regulated in patients with obesity.
Management information
Registered date
| 2016 | Year | 10 | Month | 25 | Day |
Last modified on
| 2016 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028260
