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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

September 8, 2010
July 11, 2014
April 2009
December 2015   (final data collection date for primary outcome measure)
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%.
Same as current
Complete list of historical versions of study NCT01198730 on ClinicalTrials.gov Archive Site
Hypoglycemia [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Symptoms of hypoglycemia or glucose value below 70 mg/dl after treatment with acarbose
Same as current
Not Provided
Not Provided
 
Screen of DM by OGTT in Subjects Receiving CAG or MDCT for CAD
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Diabetes Mellitus
  • Coronary Artery Disease
Drug: Acarbose
Acarbose 25 mg tid, titrate to 100 mg tid.
Other Name: Glucobay
Acarbose
Acarbose for DM patient with HbA1c > 6.5%. Add on sitagliptin if HbA1c > 7.0% after 26 weeks.
Intervention: Drug: Acarbose
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Known DM
  • Unstable disease condition
  • Pregnancy
Both
18 Years to 70 Years
No
Taiwan
 
NCT01198730
C08215
No
TCVGH, Taichung Veterans General Hospital
Taichung Veterans General Hospital
Not Provided
Principal Investigator: Wayne H-H Sheu, MD, PHD Taichung Veterans General Hospital
Taichung Veterans General Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP