The Body Constitution and Quality of Life of Diabetic

Diabetes Mellitus Clinical Trial

Official title:

The Body Constitution and Quality of Life of Diabetic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01060332
• Other study ID #: grb03484888
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2010
• Last updated: March 25, 2010
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2010
• Source: Taichung Veterans General Hospital
• Contact: Chia-I Tsai, master
• Phone: 886-4-23592525
• Email: josepho777[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Constitution Questionnaire, BCQ		1 month	No
Secondary	Diabetes Impact Measurement Scales		1 month	No