HealthyNCT00408824
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)
An observational study of Healthy and Metabolic Syndrome X, run by Nagoya University at 1 site in Japan.
Trial summary
The metabolic syndrome is a highly prevalent disorder, which causes atherosclerotic cardiovascular disease and is closely associated with insulin resistance. The alteration of the secretion of adipocytokines from accumulated visceral adipose tissue in the obese induces insulin resistance. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Metabolic Syndrome X, Hyperlipidemia
- How many people
- 4,000 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2006to not given
- Phase
- Observational
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects who work for a certain company
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Bio-information Analysis, Research Institute of Environmental Medicine, Nagoya University
Nagoya, Aichi-ken, 464-8601
Kenji Yasui, MD, PhD, +81-52-788-6211, kenji@riem.nagoya-u.ac.jp
Kenji Yasui, MD, PhD
About this study
Official title: Assessment of Genetic Risk of Metabolic Syndrome in Company Employee and Making New Health Guidance Program (NGK Study)
The metabolic syndrome is a highly prevalent disorder, which causes atherosclerotic cardiovascular disease and is closely associated with insulin resistance. The alteration of the secretion of adipocytokines from accumulated visceral adipose tissue in the obese induces insulin resistance. The purpose of this study is to identify gene polymorphisms that confer susceptibility to the metabolic syndrome and to make up a new health guidance program based on genetic risk assessment. About 25% of male employees over 45 years old in a certain company are diagnosed with the metabolic syndrome in medical examination. We, the researchers at Nagoya University, will analyze gene polymorphism and various biomarkers of over 3500 company employees.
- Conditions
- Healthy, Metabolic Syndrome X, Hyperlipidemia, Hypertension, Diabetes Mellitus
- Keywords
- insulin resistance, adipocytokine, Metabolic syndrome, Diabetes
- Medical subject headings
- Metabolic Syndrome, Hyperlipidemias, Hypertension, Diabetes Mellitus, Insulin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Investigators
- Kenji Yasui, MD, PhD, Study chair, Department of Bio-information Analysis, Research Institute of Environmental Medicine, Nagoya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408824
- Sponsor's protocol ID
- RIEM-G-3
- Status last verified
- Sep 2007
- First submitted
- 6 Dec 2006
- Last updated
- 20 Sep 2007
- Results posted
- No
Publications
Tanimura D, Shibata R, Izawa H, Hirashiki A, Asano H, Murase Y, Miyata S, Nakatochi M, Ouchi N, Ichihara S, Yasui K, Yoshida T, Naruse K, Matsubara T, Yokota M. Relation of a common variant of the adiponectin gene to serum adiponectin concentration and metabolic traits in an aged Japanese population. Eur J Hum Genet. 2011 Mar;19(3):262-9. doi: 10.1038/ejhg.2010.201. Epub 2010 Dec 8.
PubMed 21150884
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Genetic Risk of Metabolic Syndrome in Company Employee and Making New Health Guidance Program (NGK Study)
- ClinicalTrials.gov ID
- NCT00408824
- Acronym / sponsor ID
- RIEM-G-3
- Conditions
- Healthy, Metabolic Syndrome X, Hyperlipidemia, Hypertension, Diabetes Mellitus
- Keywords
- insulin resistance, adipocytokine, Metabolic syndrome, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Sep 2006
- First posted
- 7 Dec 2006 (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 metabolic syndrome is a highly prevalent disorder, which causes atherosclerotic cardiovascular disease and is closely associated with insulin resistance. The alteration of the secretion of adipocytokines from accumulated visceral adipose tissue in the obese induces insulin resistance. The purpose of this study is to identify gene polymorphisms that confer susceptibility to the metabolic syndrome and to make up a new health guidance program based on genetic risk assessment. About 25% of male employees over 45 years old in a certain company are diagnosed with the metabolic syndrome in medical examination. We, the researchers at Nagoya University, will analyze gene polymorphism and various biomarkers of over 3500 company employees.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects who work for a certain company
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
- Derived from this study: PubMed 21150884Tanimura D, Shibata R, Izawa H, Hirashiki A, Asano H, Murase Y, Miyata S, Nakatochi M, Ouchi N, Ichihara S, Yasui K, Yoshida T, Naruse K, Matsubara T, Yokota M. Relation of a common variant of the adiponectin gene to serum adiponectin concentration and metabolic traits in an aged Japanese population. Eur J Hum Genet. 2011 Mar;19(3):262-9. doi: 10.1038/ejhg.2010.201. Epub 2010 Dec 8.
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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.
Kenji Yasui, MD, PhD study chair
Department of Bio-information Analysis, Research Institute of Environmental Medicine, Nagoya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Metabolic Syndrome X, run by Nagoya 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 0 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: status not confirmed, as of the sponsor's last update on 20 Sep 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenji Yasui, MD, PhD (+81-52-788-6211, kenji@riem.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00408824, which also lists 1 linked publication.
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 20 Sep 2007.