UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002264 |
|---|---|
| Receipt number | 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 15:43:57 |
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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
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
m-hiki@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002772
