Screen of DM by OGTT in Subjects Receiving CAG or MDCT for CAD
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Taichung Veterans General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Taichung Veterans General Hospital
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01198730
First received: September 8, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 8, 2010 | ||||
| Last Updated Date | September 8, 2010 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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%. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Hypoglycemia [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] Symptoms of hypoglycemia or glucose value below 70 mg/dl after treatment with acarbose |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Screen of DM by OGTT in Subjects Receiving CAG or MDCT for CAD | ||||
| Official Title ICMJE | Screen of Diabetes Mellitus by Oral Glucose Tolerance Test in Subjects Receiving Catheterization or Multi-detector Computed Tomography (MDCT) for Coronary Artery Disease | ||||
| Brief Summary | To determine the glucose regulation status of patients who were suspected to have CAD in central Taiwan. |
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| Detailed Description | It had been reported that high prevalence of IGT and unknwon DM in patients with CAD. 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 or MDCT without known DM were eligible. After informed consent, OGTT 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Acarbose
Acarbose 25 mg tid, titrate to 100 mg tid.
Other Name: Glucobay |
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| Study Arm (s) | Acarbose
Acarbose for DM patient with HbA1c > 6.5%. Add on sitagliptin if HbA1c > 7.0% after 26 weeks.
Intervention: Drug: Acarbose |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 25 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01198730 | ||||
| Other Study ID Numbers ICMJE | C08215 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Wayne H-H Sheu, Taichung Veterans General Hospital | ||||
| Study Sponsor ICMJE | Taichung Veterans General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Taichung Veterans General Hospital | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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