UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009987 |
|---|---|
| Receipt number | 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 09:21:53 |
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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
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
Sponsor or person
Institute
Department of Cardio-Diabetes Medicine, The University of Tokushima Graduate School of Health Biosciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007650
