UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004390
Receipt number R000005241
Scientific Title The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus
Date of disclosure of the study information 2010/11/01
Last modified on 2015/04/27 11:50:14

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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 or person

Institute

Cardiovascular Division, Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.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