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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01198730
Other study ID # C08215
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2010
Last updated September 11, 2017
Start date April 2009
Est. completion date December 2019

Study information

Verified date September 2017
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patient received CAG or MDCT for suspect CAD

- Without DM history

Exclusion Criteria:

- Known DM

- Unstable disease condition

- Pregnancy

Study Design


Intervention

Drug:
Acarbose
Acarbose 25 mg tid, titrate to 100 mg tid.

Locations

Country Name City State
Taiwan Taichung Veterans General Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c and results of meal tolerance test 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%. 52 weeks
Secondary Hypoglycemia Symptoms of hypoglycemia or glucose value below 70 mg/dl after treatment with acarbose 52 weeks
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