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The Body Constitution and Quality of Life of Diabetic

Sponsor
Taichung Veterans General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01060332
Collaborator
(none)
500
Enrollment
1
Location
5.9
Duration (Months)
84.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Body Constitution Questionnaire

Detailed Description

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.

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.

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Body Constitution and Quality of Life of Diabetic
Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Jun 1, 2010
Anticipated Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
diabetics

Other: Body Constitution Questionnaire
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.
Other Names:
  • BCQ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Body Constitution Questionnaire, BCQ [1 month]

    Secondary Outcome Measures

    1. Diabetes Impact Measurement Scales [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taichung Veterans General Hospital Taichung Taiwan 40705

    Sponsors and Collaborators

    • Taichung Veterans General Hospital

    Investigators

    • Principal Investigator: Jia-I Tsai, master, Traditional Chinese Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01060332
    Other Study ID Numbers:
    • grb03484888
    First Posted:
    Feb 2, 2010
    Last Update Posted:
    Mar 26, 2010
    Last Verified:
    Mar 1, 2010

    Study Results

    No Results Posted as of Mar 26, 2010