Prospective Cohort Study of the Body Constitution Among Type II Diabetes Mellitus Patients

September 16, 2013 updated by: TCVGH, Taichung Veterans General Hospital
By analyzing the relationship between the body constitution and the progression of Type II diabetes mellitus, its morbidities, mortality and the impact of the life quality, we try to provide an useful tool, body constitution, to stratify the patients accordingly for individualized health care.

Study Overview

Status

Unknown

Conditions

Detailed Description

The study participants are recruited from the Diabetes Shared Care Network of the Taichung Veterans General Hospital (Taichung, Taiwan)

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40765
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Chia I Tsai, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1000 type II diabetes mellitus patients recruited from the Endocrinology & Metabolism out patient clinic of Taichung Veterans General Hospital.

Description

Inclusion Criteria:

  • patient diagnosed as Type II diabetes mellitus by Endocrinology specialist.
  • aged from 20 to 75 years old.
  • clear conscious, willing to join the program.

Exclusion Criteria:

  • Severe mental illness, which lead to unable to fulfill the questionaire
  • Major surgical intervention,medical events (such as acute myocardial infarction, cerebral vascular accident...et al.,), chemotherapy or radiation therapy within past one month , which made body constitution measurement unavailable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type II DM body constitution
Type II diabetes mellitus, body constitution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body constitution of type II diabetes mellitus patients
Time Frame: Two years follow up after being recruited
Two years follow up after being recruited

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality of type II diabetes mellitus patients
Time Frame: Two years follow up after being recruited
Two years follow up after being recruited
Life quality of diabetes mellitus patients
Time Frame: Two years follow up after being recruited
Two years follow up after being recruited
Diabetic retinopathy of type II diabetes mellitus patients
Time Frame: Two years follow up after being recruited
Two years follow up after being recruited
Diabetic nephropathy of type II diabetes mellitus patients
Time Frame: Two years follow up after being recruited
Two years follow up after being recruited
Diabetic neuropathy of type II diabetes mellitus patients
Time Frame: Two years follow up after being recruited
Two years follow up after being recruited

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Chia I Tsai, doctor, Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE13177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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