NCT01278628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2.3 years

First QC Date

January 18, 2011

Last Update Submit

August 8, 2016

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Components of metabolic syndrome

    every year

Study Arms (1)

Lifestyle modification

EXPERIMENTAL
Other: exercise training

Interventions

exercise trainingOTHER

exercise class once a year

Lifestyle modification

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy people and individuals with obesity and metabolic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUMCO corporation

Imari, Saga-ken, 849-4271, Japan

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

JP(1)