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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024556
Receipt No. 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

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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
Email 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
Email tomohiko@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028260

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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