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

• Conditions: Overweight or obese, non-diabetic, normotensive subjects; MedDRA version: 7.1Level: PTClassification code 10052066

• Registration Number: EUCTR2004-003986-34-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-18
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified