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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009987
Receipt No. R000007650
Scientific Title Effects of miglitol on visceral fat distribution and cardiovascular risk factors in subjects with the metabolic syndrome
Date of disclosure of the study information 2013/02/08
Last modified on 2018/08/13

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Basic information
Public title Effects of miglitol on visceral fat distribution and cardiovascular risk factors in subjects with the metabolic syndrome
Acronym miglitol and metabolic syndrome
Scientific Title Effects of miglitol on visceral fat distribution and cardiovascular risk factors in subjects with the metabolic syndrome
Scientific Title:Acronym miglitol and metabolic syndrome
Region
Japan

Condition
Condition Metabolic syndrome
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify effects of miglitol, alpha-glucosidase inhibitor, on fat distribution and cardiovascular risk factors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in visceral fat distribution and cardiovascular risk factors
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Life-style modification
Interventions/Control_2 Miglitol-treatment and Life-style modification
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 Metabolic syndrome (IDF criteria). In the IDF criteria, subjects to be defined as metabolic syndrome have: abdominal obesity (modified Japanese criteria, waist circumference >=90 cm in men and >=80 cm in women), plus any two of the following four factors; 1) hypertriglyceridemia (serum triglyceride concentration >=150 mg/dl [1.69 mmol/l]); 2) low HDL cholesterol (serum HDL cholesterol concentration <40 mg/dl [1.04 mmol/l] in men and <50 mg/dl [1.29 mmol/l] in women); 3) elevated blood pressure: systolic blood pressure >=130 mmHg and/or diastolic blood pressure >=85 mmHg; 4) high fasting glucose: serum glucose concentration >=100 mg/dl (5.6 mmol/l).
Key exclusion criteria Patients with a history of cardiovascular or cerebrovascular disease, hepatic or renal disease, diabetes mellitus or heavy smoker were excluded.
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Shimabukuro, MD, PhD
Organization Tomishiro Chuo Hospital
Division name Diabetes and Life-style Related Disease Center
Zip code
Address Ueda 25, Tomishiro City, Okinawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tomishiro Chuo Hospital
Division name Diabetes and Life-style Related Disease Center
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardio-Diabetes Medicine, The University of Tokushima Graduate School of Health Biosciences
Institute
Department

Funding Source
Organization Department of Cardio-Diabetes Medicine, The University of Tokushima Graduate School of Health Biosciences
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
2013 Year 02 Month 08 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
2006 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2006 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
2013 Year 02 Month 07 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007650

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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