Status and phase
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About
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.
Sex
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Inclusion criteria
Exclusion criteria
Currently taking any antihypertensive medications (e.g., thiazide or loop diuretics), diabetic medications, medications known to alter insulin sensitivity (e.g., statins), steroids, glucocorticoids, niacin, nicotinic acid, and anti-psychotic/depressant drugs (e.g., prozocin). Including over the counter (OTC) and herbal products, which are known to affect metabolic function.
Diagnosis of any of the following chronic diseases: hypertension, diabetes mellitus, renal insufficiency, congestive heart failure, hepatic insufficiency, biliary obstructive disorders, autoimmune disease, HIV, coronary artery disease, mental illness, and severe anemia.
Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
Unstable angina or myocardial infarction or cardiac surgery within the past 3 months.
PCI (percutaneous coronary intervention) within the past 3 months.
Stroke within the past 6 months.
Bilateral renal artery stenosis or obstructive disorders, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
Hematocrit < 35%.
Primary aldosteronism.
Hereditary fructose intolerance.
History of drug or alcohol dependency within the previous 6 months.
Currently participating in a weight loss program.
Any investigational drug therapy within one month of randomisation or during the study.
Known hypersensitivity to any component of the study drug (telmisartan or placebo).
Any circumstances the Investigator feels participation in the study would hinder subject safety or completion of the study.
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Data sourced from clinicaltrials.gov
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