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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Taichung Veterans General Hospital
Sponsor:
Information provided by (Responsible Party):
TCVGH, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01198730
First received: September 8, 2010
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Diabetes Mellitus
Coronary Artery Disease
Drug: Acarbose

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • HbA1c and results of meal tolerance test [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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:
  • Hypoglycemia [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Symptoms of hypoglycemia or glucose value below 70 mg/dl after treatment with acarbose


Estimated Enrollment: 25
Study Start Date: April 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Acarbose
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

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known DM
  • Unstable disease condition
  • Pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198730

Locations
Taiwan
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
Investigators
Principal Investigator: Wayne H-H Sheu, MD, PHD Taichung Veterans General Hospital
  More Information

No publications provided by Taichung Veterans General Hospital

Additional 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
Study First Received: September 8, 2010
Last Updated: July 11, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Taichung Veterans General Hospital:
DM
CAD
Meal tolerance test
Acarbose

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

ClinicalTrials.gov processed this record on August 28, 2014