Clinical trial NCT01060332: The Body Constitution and Quality of Life of Diabetic
Official title: The Body Constitution and Quality of Life of Diabetic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health Center for Diabetic Patient

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: 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 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.

Primary outcomes:
measure: Body Constitution Questionnaire, BCQ
timeFrame: 1 month
Secondary outcomes:
measure: Diabetes Impact Measurement Scales
timeFrame: 1 month
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Traditional Chinese Medicine
name: Jia-I Tsai, master
role: PRINCIPAL_INVESTIGATOR
References: