A Randomized, Double Blind, 2X2 Factorial Design Study to Evaluate the Effects of Telmisartan Vs Placebo, and of a Low-Glycemic Diet Vs Control Diet, in Reducing Intra-Myocellular Lipids In Individuals With Abdominal Obesity
The metabolic syndrome currently affects over 20% of the adult population in Canada.
Patients with abdominal obesity are at markedly increased risk for diabetes and heart
disease. Recent studies have shown that decreased sensitivity to insulin (insulin
resistance), a hallmark of the metabolic syndrome, is related to increased storage of fat in
muscle cells (muscle fat). Several recent studies indicate that blocking the
renin-angiotensin system (RAS) may improve insulin sensitivity and prevent the development
of type 2 diabetes. Other data suggests that this effect may be due to the effect of RAS
blockade on the recruitment and growth of adipose tissue. The primary aim of this study is
therefore to explore the role of angiotensin II in the development of insulin resistance.
Specifically, we will examine the mechanisms underlying the putative anti-diabetic effect of
RAS blockade by examining the effect of angiotensin receptor blockade on muscle fat content
in individuals with the abdominal obesity. This study will therefore test the hypothesis
that treatment with the angiotensin receptor blocker telmisartan (Micardis®) will reduce
muscle fat, thereby improving insulin sensitivity in people with abdominal obesity, with or
without additional features of the metabolic syndrome. A number of dietary factors can also
affect insulin sensitivity and may influence muscle fat. Recent studies suggest that
increasing the content of low-glycemic foods (carbohydrates which are less easily digested),
can improve insulin sensitivity and lipid profile in patients with insulin resistance. A
second aim of this study is therefore to test the hypothesis that a low-glycemic diet will
reduce muscle fat, thereby improving insulin sensitivity in this population.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
(for both interventions): change in IMCL content in the soleus muscle as assessed by 1H-MRI Spectroscopy at baseline and 6 months
Arya M Sharma, MD, FRCPC
Principal Investigator
McMaster University
Canada: Health Canada
502.433
NCT00147264
April 2004
November 2006
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