Rosiglitazone Plaque Study
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-Blind, Placebo-Controlled, Cardiovascular Magnetic Resonance (CMR) Study to Evaluate the Effect of Rosiglitazone on Carotid Atherosclerotic Plaques in Type 2 Diabetics With Vascular Disease or Hypertension|
- Plaque volume change over 12 months as assessed by cardiovascular magnetic resonance (CMR)
- Change in plaque lipid content
- Change in plaque fibrous cap thickness
- Change in plaque gadolinium enhancement as a measure of fibrous cap inflammation and plaque neovascularisation
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||May 2005|
Rosiglitazone is a new member of the thiazolidinediones (TZDs), a class of drugs which act by binding to peroxisome proliferator activated receptor gamma (PPAR-gamma). It has been suggested that the TZD class od anti-diabetic drug may exhibit anti-atherosclerotic effects. The aim of this study is to evaluate over a 12 month period the potential benefits of rosiglitazone on carotid artery atherosclerotic plaques in the type 2 diabetic population with coexisting vascular disease or hypertension. It is hypothesised that treatment with rosiglitazone will lead to a decrease in plaque size. In addition it is hoped that rosiglitazone will have a positive effect on the plaque composition and stability.
The primary endpoint will be the plaque volume change over 12 months as assessed by cardiovascular magnetic resonance (CMR). The effectiveness of this modality to evaluate the effects of pharmacological agents on atherosclerosis in vivo has been demonstrated in previous studies using statins.
The secondary endpoints will be to define the changes in plaque lipid content, fibrous cap thickness and gadolinium enhancement as a measure of fibrous cap inflammation and plaque neovascularisation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123227
|Cardiovascular Magnetic Resonance Unit, Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|
|St Mary's NHS Trust|
|London, United Kingdom, W2 1NY|
|Principal Investigator:||Dudley J Pennell, MD FRCP FACC||Cardiovascular Magnetic Resonance Unit, Royal Brompton Hospital, London UK / National Heart and Lung Institute, Imperial College, London UK|