UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Miglitol on Glucose Metabolism in Acute Coronary Syndrome
Title of the study (Brief title)	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	Koichi Node, MD. PhD.
Organization	Saga University
Division name	Department of Cardiovascular Medicine
Address	5-1-1 Nabeshima, Saga
TEL	0952-34-2364
Email	node@cc.saga-u.ac.jp

Public contact
Name of contact person	Koichi Node, MD. PhD.
Organization	Saga Univerisity
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 06 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006929