EUCTR2004-003986-34-DEActive, not recruitingNot Applicable
A randomised, double-blind, placebo-controlled, parallel group, 16-week MICARDIS® (160 mg) tablets, proof-of-concept study, evaluating insulin sensitivity in overweight or obese, non-diabetic, normotensives, using the oral glucose tolerance test, with a clamp sub-group. - MICARDIS® 160 mg, proof-of-concept in insuline sensitivity
Boehringer Ingelheim Pharma GmbH & Co. KG0 sites120 target enrollmentStarted: January 18, 2005Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
- •Subjects 18-65 years old.
- •Body Mass Index (BMI) =28.
- •HbA1C assessed =6.5%.
- •Triglycerides =150, and =500 mg/dL.
- •Fasting Glucose =126 mg/dL.
- •Blood pressure =110/64 and =140/90 mmHg
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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, glucocorticords, 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.
- •Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
Investigators
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