The Study of Sarcopenia and Aging Biomarkers by the Metab... | NCT03121326

Studies
The Study of Sarcopenia and Aging Biomarkers by the Metabolomics

NCT03121326

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

May 19, 2017Actual

Enrollment

650Estimated

Phase

Not provided

Conditions

Sarcopenia
Aging

Interventions

blood and urine sampling

Countries

Taiwan

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

Mar 2017

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

Mar 6, 2017Actual

Primary Completion Date

Mar 15, 2017Actual

Completion Date

Dec 31, 2017Estimated

First Submitted Date

Apr 17, 2017

First Submission Date that Met QC Criteria

Apr 19, 2017

First Posted Date

Apr 20, 2017Actual

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

May 17, 2017

Last Update Posted Date

May 19, 2017Actual

Name	Class
Chang Gung University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With the rapid growth of the global elderly population, the studies of the biomarkers of the sarcopenia and aging are under investigation in different ways. The investigators use Metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.

Detailed Description

Metabolomics is the emerging platform technology to address the complexity of a living system. In translational research, metabolomics approaches may enable the detection of multiple disease risk factors and interactions, disease progression, and response of patients to a particular therapy with or without side effects. Metabolomics may provide comprehensive information and improve diagnosis and prognosis which are particularly promising in human complex degenerative diseases. The investigators use Metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

650Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood and urine sampling	Diagnostic Test	Ten mL blood and 15mL urine are collected.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The biomarkers of the sarcopenia and aging in senior adults.	Metabolomics to explore the biomarkers of the sarcopenia and aging.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

residents of the Chang Gung Health and Culture Village
mostly independent and do not require nursing assistance
capable of managing their daily living activities
aged ≧ 60

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

650 residents of the Chang Gung Health and Culture Village aged over 60.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chih-Ming Lin, M.D.	Contact	886-975362603		lin789@adm.cgmh.org.tw

Overall Officials

Name	Affiliation	Role
Chih-Ming Lin, M.D.	Chang Gung Memorial Hospital	Study Chair
Mei-Ling Cheng, PhD	Chang Gung University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung University	Recruiting	Taoyuan		333	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided