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

Sponsor
Taichung Veterans General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT01198730
Collaborator
(none)
2,000
Enrollment
1
Location
188
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Apr 1, 2009
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Diabetes [3 months]

      Based on OGTT and HbA1c

    Secondary Outcome Measures

    1. Brain-derived neurotrophic factor [3 months]

      An biomarker to link brain and atheroclerosis

    2. Coroanry artery disease [3 months]

      Based on coronary angiography and medical record

    3. Mortality [5 years]

      All-cause and cardiovascular

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient received CAG or MDCT for suspect CAD

    • Without DM history

    Exclusion Criteria:

    • Known DM

    • Unstable disease condition

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taichung Veterans General Hospital Taichung Taiwan 40705

    Sponsors and Collaborators

    • Taichung Veterans General Hospital

    Investigators

    • Principal Investigator: Wayne H-H Sheu, MD, PHD, Taichung Veterans General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TCVGH, Chief in Internal medicine department, Taichung Veterans General Hospital
    ClinicalTrials.gov Identifier:
    NCT01198730
    Other Study ID Numbers:
    • C08215
    First Posted:
    Sep 10, 2010
    Last Update Posted:
    Jan 7, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by TCVGH, Chief in Internal medicine department, Taichung Veterans General Hospital
    DM
    CAD
    Meal tolerance test
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Diabetes Mellitus

    Study Results

    No Results Posted as of Jan 7, 2020