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Diabetes MellitusNCT01198730

Screen of DM by OGTT in Subjects Receiving CAG or MDCT for CAD

An observational study of Diabetes Mellitus and Coronary Artery Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine the glucose regulation status of patients who were suspected to have CAD in central Taiwan. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Coronary Artery Disease
How many people
2,000 participants
Where
1 siteTaiwan
Study dates
Apr 2009to Dec 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In this prospective observational study, we screened adult patients admitted for coronary angiography due to angina

Who may be able to join

  • Patient received CAG or MDCT for suspect CAD
  • Without DM history

Who cannot join

  • Known DM
  • Unstable disease condition
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Wayne H-H Sheu, MD, PHD, whhsheu@vghtc.gov.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Screen of Diabetes Mellitus by Oral Glucose Tolerance Test in Subjects Receiving Catheterization or Multi-detector Computed Tomography (MDCT) for Coronary Artery Disease

To determine the glucose regulation status of patients who were suspected to have CAD in central Taiwan.

Read the detailed description

It had been reported that high prevalence of IGT (impaired glucose tolerance) and unknown DM (diabetes mellitus) in patients with CAD (coronary artery disease). This study aimed to determine the glucose regulation status of patients who were suspected to have CAD in central Taiwan. In general, patient who were admitted for CAG (coronary angiography) or MDCT without known DM were eligible. After informed consent, OGTT (oral glucose tolerance test) was performed to determine the glucose regulation status. Study participants will be requested to complete questionnaires to assess their risk of diabetes and quality of sleep. Patients who were diagnosed as new DM would be asked to follow up in clinical service with diet control.

Keywords
DM, CAD, Meal tolerance test
Medical subject headings
Diabetes Mellitus, Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes

    Based on OGTT and HbA1c

    Measured: 3 months

Secondary outcomes (3)

  1. Brain-derived neurotrophic factor

    An biomarker to link brain and atheroclerosis

    Measured: 3 months

  2. Coroanry artery disease

    Based on coronary angiography and medical record

    Measured: 3 months

  3. Mortality

    All-cause and cardiovascular

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01198730
Sponsor's protocol ID
C08215
Status last verified
Jan 2020
First submitted
8 Sep 2010
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Liang KW, Lee WJ, Lee IT, Lee WL, Wang JS, Wu JP, Sheu WH. Subjects with microvascular angina have longer GT repeats polymorphism in the haem oxygenase-1 gene promoter. Biomarkers. 2020 Mar;25(2):144-148. doi: 10.1080/1354750X.2020.1713214. Epub 2020 Jan 20.

    PubMed 31916865

  • Liang KW, Sheu WH, Lee WJ, Lee WL, Fu CP, Wang JS. Differential expression of circulating vascular cell adhesion molecule-1 in subjects with coronary artery disease and cardiac syndrome X without known diabetes mellitus. Biomarkers. 2017 Dec;22(8):798-804. doi: 10.1080/1354750X.2017.1351003. Epub 2017 Jul 18.

    PubMed 28675064

  • Liang KW, Sheu WH, Lee WJ, Lee WL, Pan HC, Lee IT, Wang JS. Post-challenge insulin concentration is useful for differentiating between coronary artery disease and cardiac syndrome X in subjects without known diabetes mellitus. Diabetol Metab Syndr. 2017 Feb 8;9:10. doi: 10.1186/s13098-017-0209-1. eCollection 2017.

    PubMed 28194232

  • Wang JS, Lee IT, Lee WJ, Lin SY, Fu CP, Ting CT, Lee WL, Liang KW, Sheu WH. Performance of HbA1c and fasting plasma glucose in screening for diabetes in patients undergoing coronary angiography. Diabetes Care. 2013 May;36(5):1138-40. doi: 10.2337/dc12-1434. Epub 2012 Dec 13.

    PubMed 23238660

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Coronary Artery Disease, 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 2 inclusion and 3 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 7 Jan 2020. 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?

Diabetes (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01198730, which also lists 4 linked publications.

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 7 Jan 2020.

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Clinical Trial NCT01198730 | AzTrials