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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002264
Receipt No. R000002772
Scientific Title Effects of Miglitol on Endothelial Vascular Reactivity in Type 2 Diabetic Patients with Coronary Heart Disease
Date of disclosure of the study information 2009/07/30
Last modified on 2010/01/28

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Basic information
Public title Effects of Miglitol on Endothelial Vascular Reactivity in Type 2 Diabetic Patients with Coronary Heart Disease
Acronym J-MACH
Scientific Title Effects of Miglitol on Endothelial Vascular Reactivity in Type 2 Diabetic Patients with Coronary Heart Disease
Scientific Title:Acronym J-MACH
Region
Japan

Condition
Condition Type 2 diabetic patients with coronary heart disease
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the postprandial effects of single administration of alph-glucosidase inhibitors on changing levels of endothelial function in type 2 diabetic patients with coronary heart disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Endothelial function evaluated by plethysmography
Key secondary outcomes blood glucose, serum insulin, lipid, oxidative stress marker, inflammatory marker, incretin

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Miglitol 50mg
Interventions/Control_2 Voglibose 0.3mg
Interventions/Control_3 Placebo
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
70 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients with coronary heart disease. HbA1c <= 8% and casual blood glucose >= 200mg/dL.
Key exclusion criteria Type 1 diabetes. Patients receiving insulin therapy. Patients with one of the following clinical conditions: severe liver dysfunction, severe renal dysfunction, congestive heart failure, acute coronary syndrome within 3 months, and other severe concomitant diseases. Patients who are judged inappropriate for entry into this study by the investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Shimada
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Hiki
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL 03-3813-3111
Homepage URL
Email m-hiki@juntendo.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Juntendo University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2007 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2009 Year 08 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 28 Day
Last modified on
2010 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002772

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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