Investigation of Genetic Risk of Metabolic Syndrome in Co... | NCT00408824

Studies
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)

NCT00408824

Sponsor

Nagoya University

Status

Unknown status

Last Update Posted

Sep 20, 2007Estimated

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Healthy
Metabolic Syndrome X
Hyperlipidemia
Hypertension
Diabetes Mellitus

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 6, 2006

First Submission Date that Met QC Criteria

Dec 6, 2006

First Posted Date

Dec 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2007

Last Update Posted Date

Sep 20, 2007Estimated

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects who work for a certain company

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kenji Yasui, MD, PhD	Contact	+81-52-788-6211		kenji@riem.nagoya-u.ac.jp

Overall Officials

Name	Affiliation	Role
Kenji Yasui, MD, PhD	Department of Bio-information Analysis, Research Institute of Environmental Medicine, Nagoya University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Bio-information Analysis, Research Institute of Environmental Medicine, Nagoya University	Recruiting	Nagoya	Aichi-ken	464-8601	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21150884	Derived	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.

ID	Term
D024821	Metabolic Syndrome
D006949	Hyperlipidemias
D006973	Hypertension
D003920	Diabetes Mellitus
D007333	Insulin Resistance

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases