UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008296
Receipt number R000009776
Scientific Title Effect of alogliptin on endothelial dysfunction induced by postprandial hypelipidemia
Date of disclosure of the study information 2012/06/29
Last modified on 2013/12/16 11:07:01

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Basic information

Public title

Effect of alogliptin on endothelial dysfunction induced by postprandial hypelipidemia

Acronym

Effect of alogliptin on endothelial dysfunction induced by postprandial hypelipidemia

Scientific Title

Effect of alogliptin on endothelial dysfunction induced by postprandial hypelipidemia

Scientific Title:Acronym

Effect of alogliptin on endothelial dysfunction induced by postprandial hypelipidemia

Region

Japan


Condition

Condition

healthy volunteer

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigated the postprandial effects of a DPP4 inhibitor, alogliptin, on endothelial dysfunction and lipid profile.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in lipid profiles and endothelial function after meal loading test

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

oral adiministration of alogliptin

Interventions/Control_2

Placebo

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

Subjects with written informed consent

Key exclusion criteria

Subjects receiving hypoglycemic agetnts and/or lipid lowering agents

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama

Division name

Department of Cardiovascular Medicin

Zip code


Address

2-5-1, Shikata-cho, Okayama 700-8558, Japan

TEL

086-223-7151

Email

miyoshit@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical S

Division name

Department of Cardiovascular Medicin

Zip code


Address

2-5-1, Shikata-cho, Okayama 700-8558, Japan

TEL

086-223-7151

Homepage URL


Email

miyoshit@cc.okayama-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicin,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular Medicin,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 29 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

2012 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 06 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

2012 Year 06 Month 29 Day

Last modified on

2013 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009776


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name