The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivit… (NCT00146289) | Clinical Trial Compass
CompletedPhase 2
The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects
United States138 participantsStarted 2005-02
Plain-language summary
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
âś“. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
âś“. Subjects 18-65 years old.
âś“. Body Mass Index (BMI) \>= 28.
âś“. Sedentary life style defined as: Does not engage in vigorous activity for more than 30 minutes per day, more than two times per week.
âś“. Waist circumference \>= 40 inches (102 cm) in men and \>= 35 inches (89 cm) women.
âś“. HbA1C assessed \<= 6.5%.
âś“. Triglycerides \>= 150, and \<= 500 mg/dL.
âś“. Fasting Glucose \<= 126 mg/dL.
Exclusion criteria
âś•. 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.
âś•. 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.
âś•. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
What they're measuring
1
The primary endpoint is the change from baseline to the end of study (16 weeks) in the insulin sensitivity index as estimated by the composite index (R04-1184) calculated from a 3-hour oral glucose tolerance test (OGTT).
âś•. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
âś•. Unstable angina or myocardial infarction or cardiac surgery within the past 3 months.
âś•. PCI (percutaneous coronary intervention) within the past 3 months.
âś•. Stroke within the past 6 months.
âś•. Bilateral renal artery stenosis or obstructive disorders, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.