NCT01060332

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 26, 2010

Status Verified

March 1, 2010

Enrollment Period

5 months

First QC Date

January 29, 2010

Last Update Submit

March 25, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Constitution Questionnaire, BCQ

    1 month

Secondary Outcomes (1)

  • Diabetes Impact Measurement Scales

    1 month

Study Arms (1)

diabetics

Other: Body Constitution Questionnaire

Interventions

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.

Also known as: BCQ
diabetics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health Center for Diabetic Patient

You may qualify if:

  • 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.

You may not qualify if:

  • Took the Chinese medicine within the past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jia-I Tsai, master

    Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-I Tsai, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

March 26, 2010

Record last verified: 2010-03

Locations