The Impact of Rosiglitazone on Regression of Atherosclerosis

NCT00166803 | Suspended

• 1 other identifier: 931110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Atherosclerosis

Keywords

Diabetes Mellitus, PPARγ agonist, FDG PET

Outcome Measures

Primary Outcomes (1)

• Vulnerable plaque analyses by PET: Define plaque location and activity at baseline, and compare with the follow-up scans site by site.

  12 w

Secondary Outcomes (2)

• 1.Glycemic control after active treatment. (Fasting glucose level, HbA1c)

  12 w

• 2.Biomarkers:hs-CRP, MMP-1, MCP-1.

  12 w

Interventions

Rosiglitazone DRUG

Rosiglitazone , 4 mg daily

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type II DM patients who are aged 50 to 80 year-old with HbA1c between 7.0 to 10.0 %
• Under ≤ 2 kinds of anti-diabetic drugs.

You may not qualify if:

• Insulin use
• Patients who receive any PPARγ agonist in recent one year.
• 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.
• 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).

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 10012, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Atherosclerosis

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wei-Shiung Yang, MD, phD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 14, 2005
• Study Start: June 1, 2005
• Primary Completion: November 1, 2008
• Last Updated: January 5, 2009

Record last verified: 2008-12

Locations

TW (1)