Diabetes MellitusNCT01943214
Prospective Cohort Study of the Body Constitution Among Type II Diabetes Mellitus Patients
An observational study of Diabetes Mellitus, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Dec 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1000 type II diabetes mellitus patients recruited from the Endocrinology \& Metabolism out patient clinic of Taichung Veterans General Hospital.
Who may be able to join
- patient diagnosed as Type II diabetes mellitus by Endocrinology specialist.
- aged from 20 to 75 years old.
- clear conscious, willing to join the program.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan, 40765
Chia I Tsai, doctor, 886-4-23592525 ext. 4755, citsai777@gmail.com
Chia I Tsai, doctor
About this study
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.
Read the detailed description
The study participants are recruited from the Diabetes Shared Care Network of the Taichung Veterans General Hospital (Taichung, Taiwan)
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Body constitution
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type II DM body constitution | Type II diabetes mellitus, body constitution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body constitution of type II diabetes mellitus patients
Measured: Two years follow up after being recruited
Secondary outcomes (5)
All cause mortality of type II diabetes mellitus patients
Measured: Two years follow up after being recruited
Life quality of diabetes mellitus patients
Measured: Two years follow up after being recruited
Diabetic retinopathy of type II diabetes mellitus patients
Measured: Two years follow up after being recruited
Diabetic nephropathy of type II diabetes mellitus patients
Measured: Two years follow up after being recruited
Diabetic neuropathy of type II diabetes mellitus patients
Measured: Two years follow up after being recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TCVGH, Taichung Veterans General Hospital
- Investigators
- Chia I Tsai, doctor, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943214
- Sponsor's protocol ID
- CE13177
- Status last verified
- Sep 2013
- First submitted
- 11 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of the Body Constitution Among Type II Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT01943214
- Acronym / sponsor ID
- CE13177
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Body constitution
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study participants are recruited from the Diabetes Shared Care Network of the Taichung Veterans General Hospital (Taichung, Taiwan)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type II DM body constitution | – | –Type II diabetes mellitus, body constitution |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 type II diabetes mellitus patients recruited from the Endocrinology \& Metabolism out patient clinic of Taichung Veterans General Hospital.
Key inclusion criteria (3 listed)
- patient diagnosed as Type II diabetes mellitus by Endocrinology specialist.
- aged from 20 to 75 years old.
- clear conscious, willing to join the program.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body constitution of type II diabetes mellitus patients
Time frame: Two years follow up after being recruited
5 secondary outcomes
All cause mortality of type II diabetes mellitus patients
Time frame: Two years follow up after being recruited
Life quality of diabetes mellitus patients
Time frame: Two years follow up after being recruited
Diabetic retinopathy of type II diabetes mellitus patients
Time frame: Two years follow up after being recruited
Diabetic nephropathy of type II diabetes mellitus patients
Time frame: Two years follow up after being recruited
Diabetic neuropathy of type II diabetes mellitus patients
Time frame: Two years follow up after being recruited
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia I Tsai, doctor principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body constitution of type II diabetes mellitus patients (time frame: Two years follow up after being recruited). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.