- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00166803
The Impact of Rosiglitazone on Regression of Atherosclerosis
The Impact of Rosiglitazone on Regression of Atherosclerosis: A Serial 18F-Fluorodeoxyglucose Positron Emission Tomography Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 10012
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 w
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1.Glycemic control after active treatment. (Fasting glucose level, HbA1c)
Time Frame: 12 w
|
12 w
|
2.Biomarkers:hs-CRP, MMP-1, MCP-1.
Time Frame: 12 w
|
12 w
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wei-Shiung Yang, MD, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 931110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Atherosclerosis
-
Chinese PLA General HospitalUnknownAtherosclerosis Type 2 Diabetes Mellitus Dipeptidyl Peptidase-4 Inhibitor GLP-1
-
Seoul National University Bundang HospitalCompletedType 2 Diabetes Mellitus | Carotid AtherosclerosisKorea, Republic of
-
GuerbetCompletedType 2 Diabetes Mellitus | Coronary AtherosclerosisKorea, Republic of
-
US Department of Veterans AffairsCompletedType 2 Diabetes MellitusUnited States
-
Hospital Clinic of BarcelonaInstituto de Salud Carlos III; Institut d'Investigacions Biomèdiques August...UnknownArteriosclerosis | Type 2 Diabetes Mellitus | Diabetic Retinopathy | Carotid Atherosclerosis | MicroangiopathySpain
-
Lundquist Institute for Biomedical Innovation at...CompletedType 2 Diabetes Mellitus | Coronary Arteriosclerosis | Endothelial DysfunctionUnited States
-
Ruhr University of BochumHeart and Diabetes Center North-Rhine Westfalia; Solvay PharmaceuticalsCompletedType 2 Diabetes Mellitus | AtherosclerosisGermany
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Diabetes Mellitus | Atherosclerosis | Diabetes Mellitus, Non-insulin Dependent
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Diabetes Mellitus | Atherosclerosis | Diabetes Mellitus, Non-insulin Dependent
-
University of AlbertaCompletedAtherosclerosis | Complications of Diabetes MellitusCanada
Clinical Trials on Rosiglitazone
-
Solvay PharmaceuticalsCompletedType 2 Diabetes MellitusUnited Kingdom
-
Centre Hospitalier Universitaire DijonCompleted
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2
-
GlaxoSmithKlineCompletedNeuropathy, DiabeticNetherlands
-
Medstar Health Research InstituteGlaxoSmithKlineTerminated
-
Baskent UniversityCompletedObesity | Type 2 Diabetes MellitusTurkey
-
GlaxoSmithKlineCompletedAlzheimer's DiseaseUnited States, Australia, Spain, Bulgaria, Poland, Germany, Philippines, Singapore, Belgium, Canada, Hong Kong, Korea, Republic of, Finland, Slovenia, Czechia, France, South Africa, Sweden, Netherlands, Malaysia, United Kingdom, S...
-
Hospital Authority, Hong KongUnknownCardiovascular Diseases | Kidney Diseases | Chronic DiseaseChina
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)Completed