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 subjectsMedDRA version: 7.1Level: PTClassification code 10052066
- Registration Number
- EUCTR2004-003986-34-DK
- Lead Sponsor
- Boehringer Ingelheim Danmark A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to determine whether MICARDIS® (telmisartan 160 mg) improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects;Secondary Objective: To assess the lipid profile evolution along the treatment period;Primary end point(s): 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).
- Secondary Outcome Measures
Name Time Method