The Body Constitution and Quality of Life of Diabetic | NCT01060332

Studies
The Body Constitution and Quality of Life of Diabetic

NCT01060332

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Mar 26, 2010Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Body Constitution Questionnaire

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 2010

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

Jan 2010

Primary Completion Date

Jun 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

Jan 29, 2010

First Submission Date that Met QC Criteria

Feb 1, 2010

First Posted Date

Feb 2, 2010Estimated

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

Mar 25, 2010

Last Update Posted Date

Mar 26, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Taichung Veterans General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Diabetic Mellitus is the fifth cause of death by the report of Department of Health in 2008, and it often cause the severity of other chronic diseases. Neuropathy, retinopathy and renopathy are the most prevalent complications of DM, and they often influence the quality of life.

300 patients with Diabetic neuropathy will be recruited in Taichung Veterans General Hospital endocrine and metabolism clinics. Body Constitution Questionnaire(BCQ), Diabetes Impact Measurement Scales(DIMS), Short Form -36(SF-36) will be asked to filled up, neurological examination (NE), AC sugar, HbA1c, lipid profiles, liver and kidney functions will be measured in order to evaluate the correlation between body constitution and quality of life on patients with diabetic complication.

Detailed Description

Traditional Chinese Medicine was often prescribed to treat diabetic complications and improve the quality of life .But the study of objective evaluation of diagnostics of Traditional Chinese Medicine was few . It is important to analyze population of specific disease with well developed Traditional Chinese Medicine diagnostic tool with good validation and consistency.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diabetics			Other: Body Constitution Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Body Constitution Questionnaire	Other	Body Constitution Questionnaire was a tool for the study of objective evaluation of diagnostics of Traditional Chinese Medicine. It has been well developed with good validation and consistency.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Constitution Questionnaire, BCQ		1 month

Secondary Outcomes

Measure	Description	Time Frame
Diabetes Impact Measurement Scales		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

There is a history of diabetes and the injection or taking hypoglycemic agents.
Aged 20 years of age, not limit to male or female .
Consciousness clear, subjects are willing to sign consent after stating research purpose and process.

Exclusion Criteria:

Took the Chinese medicine within the past month.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Health Center for Diabetic Patient

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chia-I Tsai, master	Contact	886-4-23592525	4755	josepho777@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Jia-I Tsai, master	Traditional Chinese Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital	Recruiting	Taichung	Taiwan	40705	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided