UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of miglitol on visceral fat distribution and cardiovascular risk factors in subjects with the metabolic syndrome
Title of the study (Brief title)	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	Michio Shimabukuro, MD, PhD
Organization	Tomishiro Chuo Hospital
Division name	Diabetes and Life-style Related Disease Center
Address	Ueda 25, Tomishiro City, Okinawa, Japan
TEL
Email

Public contact
Name of contact person
Organization	Tomishiro Chuo Hospital
Division name	Diabetes and Life-style Related Disease Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000007650