UMIN-CTR Clinical Trial

Basic information
Public title	The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus
Acronym	The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus
Scientific Title	The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus
Scientific Title:Acronym	The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus
Region	Japan

Condition
Condition	Type 2 diabetic patients with stable angina pectoris who undergo percutaneous coronary intervention
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of dipeptidyl peptidase-4 inhibitor on microvascular function with intracoronary pressure/temperature sensor-tipped guide wire
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in index of microcirculatory index
Key secondary outcomes	Absolute and percent changes of high-sensitive CRP and adiponectine

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	DPP-4 inhibitor tretment 1 year after measurement of baseline IMR value
Interventions/Control_2	no treatment
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Stable angina pectoris 2) Type2 diabetes mellitus who are controlled well 3) Culprit lesion involving 75% or more of the stenosis without LAD 4) Successful revascularization of target lesion 5) Patients providing written consent for participattion in this clinical trial on their own volition after receiving a thorough explanation of the study
Key exclusion criteria	1) Target lesion is left main coronary artery 2) Patients on hemodialysis 3) Patients with acute coronary syndorome 4) Patients with contraindication of antiplatelet or anticoagulation drug 5) Patients who are uncontrolled diabetes mellitus 6) Patients who are judged by the principal investigator to be ineligible for enrollment in the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tohru Masuyama
Organization	Hyogo College of Medicine
Division name	Cardiovascular Division
Zip code
Address	1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL	0798-45-6553
Email

Public contact
Name of contact person	1st name Middle name Last name Masashi Fukunaga
Organization	Hyogo College of Medicine
Division name	Cardiovascular Division
Zip code
Address	1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL	0798-45-6553
Homepage URL
Email

Sponsor
Institute	Cardiovascular Division, Hyogo College of Medicine
Institute
Department

Funding Source
Organization	None
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	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 01 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	Completed
Date of protocol fixation	2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 11 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

Management information
Registered date	2010 Year 10 Month 14 Day
Last modified on	2015 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005241

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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