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The purpose of this study is to determine whether rosiglitazone, a peroxisome proliferator activated receptor gamma (PPAR-gamma) agonist, induces regression in carotid atherosclerotic plaques in diabetic patients with vascular disease and/or hypertension over a 12 month period.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Cardiovascular Magnetic Resonance Unit, Royal Brompton Hospital
Active, not recruiting
Royal Brompton & Harefield NHS Foundation Trust
Published on BioPortfolio: 2014-08-27T03:52:49-0400
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A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.
A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.
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