UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Cardiovascular Medicine, Saga University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

06

Month

29

Day

Last modified on

2017

Year

07

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006929