We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01198730
Recruitment Status : Recruiting
First Posted : September 10, 2010
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):
TCVGH, Taichung Veterans General Hospital

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

Condition or disease Intervention/treatment
Diabetes Mellitus Coronary Artery Disease Drug: Acarbose

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 after 6-12 months with diet control. Treatment with oral anti-diabetic drug may be needed if HbA1c target was not reached.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : April 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose
U.S. FDA Resources

Arm Intervention/treatment
Acarbose for DM patient with HbA1c > 6.5%. Add on sitagliptin if HbA1c > 7.0% after 26 weeks.
Drug: Acarbose
Acarbose 25 mg tid, titrate to 100 mg tid.
Other Name: Glucobay

Primary Outcome Measures :
  1. HbA1c and results of meal tolerance test [ Time Frame: 52 weeks ]
    Patient who was diagnosed with DM after an OGTT was asked to follow up HbA1c after 6-12 months. Acarbose was given for those who had HbA1c > 6.5%. After 26 weeks, sitagliptin was given for those who had HbA1c > 7.0%.

Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: 52 weeks ]
    Symptoms of hypoglycemia or glucose value below 70 mg/dl after treatment with acarbose

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198730

Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Wayne H-H Sheu, MD, PHD       whhsheu@vghtc.gov.tw   
Sponsors and Collaborators
Taichung Veterans General Hospital
Principal Investigator: Wayne H-H Sheu, MD, PHD Taichung Veterans General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: TCVGH, Chief in Internal medicine department, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01198730     History of Changes
Other Study ID Numbers: C08215
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by TCVGH, Taichung Veterans General Hospital:
Meal tolerance test

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs