Metabolic SyndromePhase 1NCT01278628
SUMCO Metabolic Syndrome Project
A Phase 1 study testing exercise training in people with Metabolic Syndrome, run by Fukuoka University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2009to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy people and individuals with obesity and metabolic syndrome
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Metabolic Syndrome
- Being tested
- exercise training
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
exercise class once a year
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Experimental | Not described Receives: Other: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Components of metabolic syndrome
Measured: every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fukuoka University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuichiro Nishida, Fukuoka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278628
- Sponsor's protocol ID
- 19200049sagasumco
- Status last verified
- Aug 2016
- First submitted
- 18 Jan 2011
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUMCO Metabolic Syndrome Project
- ClinicalTrials.gov ID
- NCT01278628
- Acronym / sponsor ID
- 19200049sagasumco
- Conditions
- Metabolic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Fukuoka UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Experimental | Other: exercise training |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy people and individuals with obesity and metabolic syndrome
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise trainingexercise class once a year | Other | Lifestyle modification |
Primary outcome
Components of metabolic syndrome
Time frame: every year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exercise training in people with Metabolic Syndrome, run by Fukuoka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Components of metabolic syndrome (time frame: every year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.