UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002342 |
|---|---|
| Receipt number | 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 13:48:09 |
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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
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
takeshi@kumamoto-u.ac.jp
Sponsor or person
Institute
Metabolic medicine, Faculty of medical and pharmaceutical sciences, Kumamoto University.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002869
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
