Diabetes Mellitus, Type 2NCT01990638
Effects of Exercise Therapy on Ventricular and Endothelial Function in Patients After Coronary Artery Bypass Surgery
An observational study of Diabetes Mellitus, Type 2, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study was (1) to compare the peak exercise capacity and left ventricular diastolic function between patients with and without diabetes and (2) to investigate the interrelation among peak oxygen consumption, left ventricular diastolic function, blood sugar, and lipid profile. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- exercise capacity test
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2004to May 2005
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients after coronary artery bypass surgery
Who may be able to join
- well-controlled diabetes
- no history of myocardial infarction
- stable post coronary artery bypass surgery for at least 3 months
Who cannot join
- heart failure,
- valvular disease,
- abnormal kidney or liver function,
- cerebrovascular disease,
- primary pulmonary disease,
- other systemic or acute illness that may impede the testing or training
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was (1) to compare the peak exercise capacity and left ventricular diastolic function between patients with and without diabetes and (2) to investigate the interrelation among peak oxygen consumption, left ventricular diastolic function, blood sugar, and lipid profile.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- exercise capacity test
- Keywords
- coronary artery bypass graft, Diabetes mellitus, type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise capacity testOther
| Study group | Role | What they receive |
|---|---|---|
| DM group | Not described Receives: Other: exercise capacity test | |
| non-DM group | Not described Receives: Other: exercise capacity test |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular diastolic function
echocardiographic parameters
Measured: 1 week
Secondary outcomes (2)
flow-mediated dilation
flow-mediated dilation on right brachial artery
Measured: 1 week
exercise capacity
oxygen consumption
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2004
- Primary completionApr 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Tai Wu, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990638
- Sponsor's protocol ID
- 9361701193
- Status last verified
- Nov 2013
- First submitted
- 15 Nov 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Therapy on Ventricular and Endothelial Function in Patients After Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01990638
- Acronym / sponsor ID
- 9361701193
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- coronary artery bypass graft, Diabetes mellitus, type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 21 Nov 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.
The purpose of this study was (1) to compare the peak exercise capacity and left ventricular diastolic function between patients with and without diabetes and (2) to investigate the interrelation among peak oxygen consumption, left ventricular diastolic function, blood sugar, and lipid profile.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DM group | – | Other: exercise capacity test |
| non-DM group | – | Other: exercise capacity test |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients after coronary artery bypass surgery
Key inclusion criteria (3 listed)
- well-controlled diabetes
- no history of myocardial infarction
- stable post coronary artery bypass surgery for at least 3 months
Key exclusion criteria (6 listed)
- heart failure,
- valvular disease,
- abnormal kidney or liver function,
- cerebrovascular disease,
- primary pulmonary disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise capacity test | Other | DM group, non-DM group |
Primary outcome
left ventricular diastolic function
Time frame: 1 week
echocardiographic parameters
2 secondary outcomes
flow-mediated dilation
Time frame: 1 week
exercise capacity
Time frame: 1 week
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 21 Nov 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.
Ying-Tai Wu, PhD study director
National Taiwan University 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, Type 2, run by National Taiwan University 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 6 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 21 Nov 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?
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.
What does the primary outcome measure?
left ventricular diastolic function (time frame: 1 week). 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 21 Nov 2013.