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The Body Constitution and Quality of Life of Diabetic

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060332
First Posted: February 2, 2010
Last Update Posted: March 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taichung Veterans General Hospital
  Purpose

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 Intervention
Diabetes Mellitus Other: Body Constitution Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Body Constitution and Quality of Life of Diabetic

Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Body Constitution Questionnaire, BCQ [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Diabetes Impact Measurement Scales [ Time Frame: 1 month ]

Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: BCQ

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Health Center for Diabetic Patient
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060332


Contacts
Contact: Chia-I Tsai, master 886-4-23592525 ext 4755 josepho777@yahoo.com.tw

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Chia-I Tsai, master    886-4-23592525 ext 4755    josepho777@yahoo.com.tw   
Principal Investigator: Chia-I Tsai, master         
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Jia-I Tsai, master Traditional Chinese Medicine
  More Information

Responsible Party: Chia-I Tsai/Visiting Staff, Traditional Chinese Medicine Department
ClinicalTrials.gov Identifier: NCT01060332     History of Changes
Other Study ID Numbers: grb03484888
First Submitted: January 29, 2010
First Posted: February 2, 2010
Last Update Posted: March 26, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases