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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002342
Receipt No. R000002869
Scientific Title Effect of a group-based lifestyle intervention on risk factors and insulin resistance for metabolic syndrome
Date of disclosure of the study information 2009/09/01
Last modified on 2009/08/17

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Basic information
Public title Effect of a group-based lifestyle intervention on risk factors and insulin resistance for metabolic syndrome
Acronym Tabaruzaka study
Scientific Title Effect of a group-based lifestyle intervention on risk factors and insulin resistance for metabolic syndrome
Scientific Title:Acronym Tabaruzaka study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and sustained effects of two kind of group-based lifestyle interventions for the metabolic syndrome and the relationship between intervention effects and improvement of insulin sensitivity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The effect of components of MS and insulin sensitivity after 10 months and further after 2 years of intervention.
Key secondary outcomes The effect of BMI, blood pressure, lipid, blood glucose after 10 months and further after 2 years of intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 standard (S: 4-month intervention)
Interventions/Control_2 intensive intervention (I: 10-month intervention)
Interventions/Control_3 control group.
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
30 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria people who have at least one or more of the following criteria: obesity (BMI => 25); elevated BP (130 <= SBP < 160 mmHg or 85 <= DBP < 100 mmHg); dyslipidemia (LDL- C => 140 mg/dl, Triglyceride (TG) => 150 mg/dl or HDL-C < 40 mg/dl for male or HDL-C < 50 mg/dl for female); and impaired glucose homeostasis (110 <= FBS < 126 mg/dl, 140 <= BS at 120 min of 75g oral glucose tolerance test (75gOGTT) < 200 mg/dl, or 5.5 <= A1c < 6.1 %)
Key exclusion criteria The subjects who take medication for hypertension, dyslipidemia and diabetes.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Araki
Organization Faculty of medical and pharmaceutical sciences, Kumamoto University.
Division name Metabolic medicine
Zip code
Address 1-1-1, Honjo, Kumamoto, 860-8556, Japan.
TEL +81-96-373-5169
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nishikawa
Organization Faculty of medical and pharmaceutical sciences, Kumamoto University.
Division name Metabolic medicine
Zip code
Address 1-1-1, Honjo, Kumamoto, 860-8556, Japan.
TEL +81-96-373-5169
Homepage URL
Email takeshi@kumamoto-u.ac.jp

Sponsor
Institute Metabolic medicine, Faculty of medical and pharmaceutical sciences, Kumamoto University.
Institute
Department

Funding Source
Organization Kokuho health-up model
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Preventive and Environmental Medicine Kumamoto University.
Name of secondary funder(s) Metabolic medicine, Faculty of medical and pharmaceutical sciences, Kumamoto University.

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
2009 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
After 10 months, Standard(S) and Intensive(I) intervention showed improvements of BMI , HDL-C, FBS, A1c and mean number of components of MS. Further after 2 years, sustained effect on BMI was observed in S and I. No change in mean number of components of MS from baseline in S and I and a significant increase in that of Control group were observed. An insulin sensitivity index and a hepatic insulin resistance index were improved after intervention. The improvements of components of MS were correlated with the increase in WBISI.
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
2003 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 08 Month 01 Day
Last follow-up date
2006 Year 09 Month 01 Day
Date of closure to data entry
2006 Year 09 Month 01 Day
Date trial data considered complete
2006 Year 09 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 17 Day
Last modified on
2009 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002869

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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