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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005874
Receipt No. R000006929
Scientific Title Effect of Miglitol on Glucose Metabolism in Acute Coronary Syndrome
Date of disclosure of the study information 2011/06/29
Last modified on 2017/07/03

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Basic information
Public title Effect of Miglitol on Glucose Metabolism in Acute Coronary Syndrome
Acronym MACS Study
Scientific Title Effect of Miglitol on Glucose Metabolism in Acute Coronary Syndrome
Scientific Title:Acronym MACS Study
Region
Japan

Condition
Condition Hospitalization by ACS patient with type II diabetes.
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the effect of postprandial hyperglycemia control by administrating miglitol for patients with ACS in both short term and long term.
In the short term, performing
Continuous Glucose Monitoring:CGM, we examine the changes in biomarkers, such as blood glucose fluctuation, cardiac function, and inflammatory biomarker. In the long term, we evaluate the prognosis including the cardiovascular event.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Short Term Evaluation
Compare the blood glucose level of biomarkers including inflammatory, CBM, cardiac and renal functions through the hospitalization. (before and after the inserting CGM)
2)Long Term Evaluation
Evaluate the data taken 1months and 3 months and 6 months after the medication.
The cardiac event, glucose tolerance, lipid,renal fanction,echocardiography, biomarker, and blood vessel function tests will be compared.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Migtol administrated group: 48 hours after CGM, 50mg migtol will be administrated 3 days in a day before each meal. It will be continued for 6 months.
Interventions/Control_2 - Non administrated group: continue ordinary treatment with combination of alimentary and exercise therapy for 6 months.
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1)Patients who are hospitalized for ACS such as cardiac infarction, unstable angina. (within 7days of onset)
(2)
(3)Type II diabetes:Patients with less 9 % of HbA1c(JDS)
(4)Age: older than 20 and less than 80-year-old when agreement is acquired.
(5)Gender:regardless
(6)Patient with full understanding of this study and agrees with written consent. The agreement must be based on the patients' free will.
Key exclusion criteria (1)patient suspected of type I diabetes mellitus
(2)patient under insulin treatment
(3)Patient who has already taking alpha-Gl.
(4)patient with serious liver disease
(5)patient with history of type B or C hepatitis.
(6)patients with serious kidney disease, and whose serum creatinine level is higher than 2.0mg/dL
(7)patient with history of digestive system operation, such as gastric resection
(8) Patients with history of allergy and hypersensitivity
(9)Pregnant and/or breathbeeding, child-bearing potential women.
(10)blood glucose level is more than 400mg/dL or less than 40mg/dL
(11)patients who was diagnosed that his/her condition is not appropriate to join this study.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Node, MD. PhD.
Organization Saga University
Division name Department of Cardiovascular Medicine
Zip code
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2364
Email node@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Node, MD. PhD.
Organization Saga Univerisity
Division name Department of Cardiovascular Medicine
Zip code
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2364
Homepage URL
Email node@cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga University
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

Other administrative information
Date of disclosure of the study information
2011 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 Main results already published
Date of protocol fixation
2011 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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
2011 Year 06 Month 29 Day
Last modified on
2017 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006929

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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