Back to resultsSUMCO Metabolic Syndrome Project
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
exercise training
Sponsored by
About this trial
This is an interventional health services research trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- healthy people and individuals with obesity and metabolic syndrome
Exclusion Criteria:
-
Sites / Locations
- SUMCO corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle modification
Arm Description
Outcomes
Primary Outcome Measures
Components of metabolic syndrome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01278628
Brief Title
SUMCO Metabolic Syndrome Project
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fukuoka University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Physical activity is considered important in prevention and treatment of obesity and metabolic syndrome. Genotype of genes involved in metabolism is also known to be associated with the development of metabolic syndrome. However, scarce evidence exists regarding the influence of physical activity intensity and genotype on metabolic syndrome in people with obesity. The investigators examine physical activity using an uniaxial accelerometer, as well as aerobic fitness using an electric bicycle ergometer, several genotypes of genes related to glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal obesity who were employees in silicon wafer manufacture and participated in a health checkup.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle modification
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
exercise training
Intervention Description
exercise class once a year
Primary Outcome Measure Information:
Title
Components of metabolic syndrome
Time Frame
every year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy people and individuals with obesity and metabolic syndrome
Exclusion Criteria:
-
Facility Information:
Facility Name
SUMCO corporation
City
Imari
State/Province
Saga
ZIP/Postal Code
849-4271
Country
Japan
12. IPD Sharing Statement
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SUMCO Metabolic Syndrome Project
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