UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect on GLP-1 receptor expression in human artery with Type2 diabetes
Title of the study (Brief title)	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	Tomohiko Kimura
Organization	Kawasaki Medical School
Division name	Division of Diabetes, Endocrinology and Metabolism
Address	Matsushima 577, Kurashiki, Okayama, Japan
TEL	086-462-1111
Email	tomohiko@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Tomohiko Kimura
Organization	Kawasaki Medical School
Division name	Division of Diabetes, Endocrinology and Metabolism
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	GLP-1 receptor gene expression in human artery was down-regulated in subjects with obesity.
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028260