Treatment of Coronary Atherosclerosis by Insulin Sensitizers in Insulin-Resistant Patients

• Status: Unknown status
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 progression and compositional change of non-obstructive coronary atherosclerotic plaques and coronary calcification by serial intravascular ultrasound (IVUS)/multi-detector-row computed tomography (MDCT) follow-up in patients with type 2 diabetes or non-diabetic metabolic syndrome during a 2-year period.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Insulin; Insulin, Globin Zinc; Pioglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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