NCT01943214

Brief Summary

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.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Typical duration 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

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

3.4 years

First QC Date

September 11, 2013

Last Update Submit

September 16, 2013

Conditions

Keywords

Diabetes MellitusBody constitution

Outcome Measures

Primary Outcomes (1)

  • Body constitution of type II diabetes mellitus patients

    Two years follow up after being recruited

Secondary Outcomes (5)

  • All cause mortality of type II diabetes mellitus patients

    Two years follow up after being recruited

  • Life quality of diabetes mellitus patients

    Two years follow up after being recruited

  • Diabetic retinopathy of type II diabetes mellitus patients

    Two years follow up after being recruited

  • Diabetic nephropathy of type II diabetes mellitus patients

    Two years follow up after being recruited

  • Diabetic neuropathy of type II diabetes mellitus patients

    Two years follow up after being recruited

Study Arms (1)

Type II DM body constitution

Type II diabetes mellitus, body constitution

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40765, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Chia I Tsai, doctor

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taichung Veterans General Hospital

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 16, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations