Status:
UNKNOWN
Treatment of Coronary Atherosclerosis by Insulin Sensitizers in Insulin-Resistant Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Coronary Atherosclerosis
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In this study, we, the investigators at National Taiwan University Hospital, will evaluate the efficacy of pharmacological therapy targeted to reduce insulin resistance (pioglitazone) on the progressi...
Detailed Description
Background: Type 2 diabetes and its antecedent, metabolic syndrome, are important risk factors for premature and accelerated atherosclerotic cardiovascular diseases. However, glycemic control by provi...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and the presence of type 2 diabetes mellitus or metabolic syndrome, not currently treated by thiazolidinediones. Diagnosis of metabolic syndrome is determined by criteria defined by the National Cholesterol Education Program Adult Treatment Panel III, modified to use World Health Organization (WHO) proposed waist circumference cut-points for Asians. Therefore, this requires subjects to have three or more of the following criteria:
- waist circumference of \> 90 cm in men and \> 80 cm in women;
- serum triglycerides of \>= 150 mg/dl;
- high-density lipoprotein-cholesterol (HDL-C) levels of \< 40 mg/dl in men and \< 50 mg/dl in women;
- impaired fasting glucose of 110 to 125 mg/dl; or
- blood pressure of \>= 130/85 mmHg or treated hypertension.
- Patients with objective documentation of myocardial ischemia undergoing percutaneous coronary angiography and the coronary arteriogram showing one or more ≥ 20% and \< 70% stenosis, which will be left untreated at physician's discretion, in at least one coronary artery
- The baseline MDCT coronary angiogram revealing one or more discernible plaque(s) untreated by stenting in at least one coronary artery
- Ability to perform all tasks related to glycemic control and risk factor management
- Written informed consent signed
Exclusion
- Class III or IV heart failure
- Creatinine \> 2.0 mg/dl
- Hepatic disease (ALT \> 3 times the upper limit of normal)
- Poorly controlled diabetes mellitus (hemoglobin A1c \[HbA1c\] \> 13%)
- Fasting triglycerides \> 1000 mg/dl in the presence of moderate glycemic control (HbA1c \< 9.0%)
- Non-cardiac illness expected to limit survival to less than two years
- Current alcohol or drug abuse
- Chronic steroid use judged to interfere with the control of diabetes, exceeding 10 mg
- Unable to understand or cooperate with protocol requirements
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00155350
Start Date
November 1 2004
End Date
December 1 2007
Last Update
February 27 2006
Active Locations (1)
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1
Division of Cardiology, Department of Internal Medicine and Department of Medical Imaging, National Taiwan University Hospital
Taipei, Taiwan, 100