HealthyNCT00916019
Investigation of the Effects of Exercise on Gene Expression
A study testing exercise training in people with Healthy, run by Fukuoka University at 1 site in Japan.
Trial summary
The investigators have previously shown that mild exercise training at the level of lactate threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity and insulin-independent glucose disposal of glucose effectiveness, without changes in body weight and body fat (Nishida et al, Diabetes… Read more about this study
- Who is it for?
- Ages 19 to 32 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2002to Dec 2007
- Phase
- Interventional
- 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 19 to 32 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men who were all in good health
- All individuals were free from diabetes and none were taking any medications
- All subjects were asked not to change their normal dietary habits, and not to engage in any strenuous physical activity
Who cannot join
- People who undergone regular exercise for at least 2 years
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on Gene Expression and Gene Marker Accompanied by a Single Bout of Exercise and Exercise Training
The investigators have previously shown that mild exercise training at the level of lactate threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity and insulin-independent glucose disposal of glucose effectiveness, without changes in body weight and body fat (Nishida et al, Diabetes Care, 2001; Nishida et al, Diabetes, 2004). Thus these beneficial effects are likely related to a number of adaptations that occur in skeletal muscle as response to exercise. In the current study, the investigators hypothesised that a single bout of mild exercise performed at LT would be a physiological stimulator of skeletal muscle PGC-1alpha gene, and the repetition of this exercise stimulating PGC-1alpha gene (i.e., training) for 12 weeks would induce coordinated increases in a large number of metabolic genes, as well as other genes potentially important in the prevention of insulin resistance and metabolic syndrome.
- Conditions
- Healthy
- Being tested
- exercise training
- Keywords
- gene expression, skeletal muscle, Healthy men
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
60 min of low-intensity exercise, 5 days/week, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | mild exercise training Receives: Other: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle PGC-1alpha gene expression and mitochondrial gene expression
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJul 2002
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fukuoka University
- Sponsor type
- University, hospital or other
- Investigators
- Hiroaki Tanaka, Ph.D., Principal investigator, Fukuoka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916019
- Sponsor's protocol ID
- 19200049
- Status last verified
- Jun 2009
- First submitted
- 4 Jun 2009
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Gene Expression and Gene Marker Accompanied by a Single Bout of Exercise and Exercise Training
- ClinicalTrials.gov ID
- NCT00916019
- Acronym / sponsor ID
- 19200049
- Conditions
- Healthy
- Keywords
- gene expression, skeletal muscle, Healthy men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fukuoka UniversityUniversity, hospital or other
- Study start
- Jul 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Jun 2009 (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.
The investigators have previously shown that mild exercise training at the level of lactate threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity and insulin-independent glucose disposal of glucose effectiveness, without changes in body weight and body fat (Nishida et al, Diabetes Care, 2001; Nishida et al, Diabetes, 2004). Thus these beneficial effects are likely related to a number of adaptations that occur in skeletal muscle as response to exercise. In the current study, the investigators hypothesised that a single bout of mild exercise performed at LT would be a physiological stimulator of skeletal muscle PGC-1alpha gene, and the repetition of this exercise stimulating PGC-1alpha gene (i.e., training) for 12 weeks would induce coordinated increases in a large number of metabolic genes, as well as other genes potentially important in the prevention of insulin resistance and metabolic syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: exercise trainingmild exercise training |
Who may qualify
- Ages
- 19 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men who were all in good health
- All individuals were free from diabetes and none were taking any medications
- All subjects were asked not to change their normal dietary habits, and not to engage in any strenuous physical activity
Key exclusion criteria (2 listed)
- People who undergone regular exercise for at least 2 years
- Smokers
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 training60 min of low-intensity exercise, 5 days/week, 12 weeks | Other | exercise |
Primary outcome
Skeletal muscle PGC-1alpha gene expression and mitochondrial gene expression
Time frame: 3 months
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 16 Jun 2009.
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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.
Hiroaki Tanaka, Ph.D. principal investigator
Fukuoka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Healthy, 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 3 inclusion and 2 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 16 Jun 2009. 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.
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?
Skeletal muscle PGC-1alpha gene expression and mitochondrial gene expression (time frame: 3 months). 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 16 Jun 2009.