Type 2 Diabetes MellitusNCT01151293
Personality of Diabetic Patients Will Influence Their Medical compliance-a 5 Years Cohort Follow up With Type D Personality
An observational study of Type 2 Diabetes Mellitus, run by Far Eastern Memorial Hospital.
Trial summary
Diabetes is one of the most common causes of death in Taiwan. With the raising prevalence of diabetes, it became the fourth most common cause of death since 2002. Up to one-tenth of the national health insurance expenditure was used directly in diabetic care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 2009to Apr 2010
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: T2DM patients for OPD Age 18-80 y/o Inform consent
Who may be able to join
- T2DM patients for OPD
- Age 18-80 y/o
- Inform consent
Who cannot join
None listed.
About this study
Diabetes is one of the most common causes of death in Taiwan. With the raising prevalence of diabetes, it became the fourth most common cause of death since 2002. Up to one-tenth of the national health insurance expenditure was used directly in diabetic care. Besides, more expenditure was used in the management of the complications of diabetes, like vascular diseases, renal disease, blindness and neuropathy. Diabetes is a chronic disease, the target treatment is to control HbA1c below 7%, by intensive life style modification, diet control, exercise and medications. Diabetic patient should have a good medical compliance, in order to prevent the tragedy of the complication. A good medical compliance is depended on the individual personality. Personality is the major cause of chronic stress, which is one of the most important cause of psychological stress and the risk factors of the vascular disease and hypertension. Recently, Type D personality had shown the close relationship with patients' prognosis, morbidity, mortality and life quality in different vascular diseases. These vascular diseases are the result of the atherosclerotic process, and diabetes is one of the most important risk factors of the atherosclerotic changes. The investigators believed that type D personality may also affect the medical compliance, the severity (in terms of HbA1c), and the prognosis of diabetic patients. The first part of this study is a cross sectional study, the investigators will try to figure out the relationship of the type D personality toward diabetic medical compliance, and their comorbidity. The second part of this study is a cohort study, base on the population in first part of the study, the investigators will like to construct the correlation of type D personality and diabetic patients' 5-years complication and mortality. The investigators want to establish a more complete vascular care system, improve the medical compliance, lower the complication rates, and improved the quality of life.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type D personality, diabetes, medical compliance, HbA1c, complication, mortality, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lung Chan, M.D., M. Sc., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151293
- Sponsor's protocol ID
- 098011-3
- Status last verified
- Jul 2009
- First submitted
- 24 Jun 2010
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality of Diabetic Patients Will Influence Their Medical compliance-a 5 Years Cohort Follow up With Type D Personality
- ClinicalTrials.gov ID
- NCT01151293
- Acronym / sponsor ID
- 098011-3
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type D personality, diabetes, medical compliance, HbA1c, complication, mortality, T2DM
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2010 (actual)
- First posted
- 28 Jun 2010 (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.
Diabetes is one of the most common causes of death in Taiwan. With the raising prevalence of diabetes, it became the fourth most common cause of death since 2002. Up to one-tenth of the national health insurance expenditure was used directly in diabetic care. Besides, more expenditure was used in the management of the complications of diabetes, like vascular diseases, renal disease, blindness and neuropathy. Diabetes is a chronic disease, the target treatment is to control HbA1c below 7%, by intensive life style modification, diet control, exercise and medications. Diabetic patient should have a good medical compliance, in order to prevent the tragedy of the complication. A good medical compliance is depended on the individual personality. Personality is the major cause of chronic stress, which is one of the most important cause of psychological stress and the risk factors of the vascular disease and hypertension. Recently, Type D personality had shown the close relationship with patients' prognosis, morbidity, mortality and life quality in different vascular diseases. These vascular diseases are the result of the atherosclerotic process, and diabetes is one of the most important risk factors of the atherosclerotic changes. The investigators believed that type D personality may also affect the medical compliance, the severity (in terms of HbA1c), and the prognosis of diabetic patients. The first part of this study is a cross sectional study, the investigators will try to figure out the relationship of the type D personality toward diabetic medical compliance, and their comorbidity. The second part of this study is a cohort study, base on the population in first part of the study, the investigators will like to construct the correlation of type D personality and diabetic patients' 5-years complication and mortality. The investigators want to establish a more complete vascular care system, improve the medical compliance, lower the complication rates, and improved the quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- T2DM patients for OPD Age 18-80 y/o Inform consent
Key inclusion criteria (3 listed)
- T2DM patients for OPD
- Age 18-80 y/o
- Inform consent
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
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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.
Lung Chan, M.D., M. Sc. principal investigator
Far Eastern Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Far Eastern Memorial Hospital.
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 0 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: finished, as of the sponsor's last update on 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 28 Jun 2010; AzTrials last refreshed its copy on 8 Nov 2026.