The Impact of Rosiglitazone on Regression of Atherosclerosis

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Cardiovascular events are the leading cause of death in developed countries worldwide, including Taiwan. The disruption of atherosclerotic plaques and the subsequent formation of thrombi are currently recognized as the major cause of morbidity and mortality of cardiovascular diseases. Therefore, early detection of vulnerable plaques is clinically important for risk stratification and also to provide early treatment. Several imaging approaches have been adapted to detect vulnerable plaques, however, most of them are based on morphologic characteristics of atheroma. We hypothesize that PPARγ-induced plaque regression could be monitored clinically by use of 18FDG PET/CT approach, which could assess the inflammatory activity, and can be detected noninvasively earlier than previously reported.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: National Science Council, Taiwan
• Treatments: Rosiglitazone

Criteria

Inclusion Criteria:

1. Type II DM patients who are aged 50 to 80 year-old with HbA1c between 7.0 to 10.0 %

2. Under ≤ 2 kinds of anti-diabetic drugs.

Exclusion Criteria:

1. Insulin use

2. Patients who receive any PPARγ agonist in recent one year.

3. Women of child-bearing potential are excluded (i.e. menopausal women or post-hysterectomy women are included in this study) due to radiation exposure in this study.

4. Significant concomitant disease such as active infection, malignancy, hepatic or renal dysfunction at the time of enrollment (i.e. T-Bil > 3 mg/dl，ALT > 2.5 times the upper limit of normal range and Creatinine > 3 mg/dl in our hospital).