The Impact of Rosiglitazone on Regression of Atherosclerosis

This study has suspended participant recruitment.
(no fund)
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166803
First received: September 11, 2005
Last updated: January 2, 2009
Last verified: December 2008
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Atherosclerosis
Drug: Rosiglitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Rosiglitazone on Regression of Atherosclerosis: A Serial 18F-Fluorodeoxyglucose Positron Emission Tomography Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Vulnerable plaque analyses by PET: Define plaque location and activity at baseline, and compare with the follow-up scans site by site. [ Time Frame: 12 w ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1.Glycemic control after active treatment. (Fasting glucose level, HbA1c) [ Time Frame: 12 w ] [ Designated as safety issue: Yes ]
  • 2.Biomarkers:hs-CRP, MMP-1, MCP-1. [ Time Frame: 12 w ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2005
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosiglitazone
    Rosiglitazone , 4 mg daily
Detailed Description:

The early detection of vulnerable plaques is clinically important for risk stratification and also to provide early treatment.Inflammation is important in the both pathogenesis and outcome of atherosclerosis. Plaques containing numerous inflammatory cells, particular macrophages, have a high risk of rupture. Diabetes is a major risk factor for the development of atherosclerosis. The discovery of the peroxisome proliferator-activated receptor γ (PPARγ) gene led to the hope of favorably influencing the insulin resistance syndrome. The administration of PPARγ agonists have been shown to reduce insulin resistance, to reduce the expression of leptin, to lower plasma free fatty acid level and to lower blood pressure. Moreover, beyond the glucose effect, PPARγ agonists may theoretically affect atherosclerosis also through the inhibition of inflammatory cytokines secreted from the macrophage, such as IL-6, IL-1β, TNF-α, etc. These evidences highlight the possibility of PPARγ agonists could be have great impact on plaque regression.

18FDG is a glucose analogue that is taken up by cells in proportion to their metabolic activity. Several papers have reported the potential roles of metabolic imaging in the assessment of inflammatory vascular diseases, especially in large vessels. However, PET has limited spatial resolution. Recently, a combined PET/CT is emerged as a promising modality which could provide both anatomical and functional information. We hypothesize that PPARγ agonists-induced plaque regression could be monitored clinically by use of 18FDG PET/CT approach, and providing information of early efficacy PPARγ treatment caused by stabilization of vulnerable plaque without affecting the lumen size.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00166803

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10012
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Wei-Shiung Yang, MD, phD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Pan-Chyr Yang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00166803     History of Changes
Other Study ID Numbers: 931110
Study First Received: September 11, 2005
Last Updated: January 2, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Diabetes Mellitus, PPARγ agonist, FDG PET

Additional relevant MeSH terms:
Atherosclerosis
Diabetes Mellitus
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014