The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects
NCT ID: NCT00146289
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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MICARDIS® (telmisartan)
Eligibility Criteria
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Inclusion Criteria
2. Subjects 18-65 years old.
3. Body Mass Index (BMI) \>= 28.
4. Sedentary life style defined as: Does not engage in vigorous activity for more than 30 minutes per day, more than two times per week.
5. Waist circumference \>= 40 inches (102 cm) in men and \>= 35 inches (89 cm) women.
6. HbA1C assessed \<= 6.5%.
7. Triglycerides \>= 150, and \<= 500 mg/dL.
8. Fasting Glucose \<= 126 mg/dL.
9. Blood pressure \>= 110/64 and \<= 140/90 mmHg.
Exclusion Criteria
2. 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.
3. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
4. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
5. Unstable angina or myocardial infarction or cardiac surgery within the past 3 months.
6. PCI (percutaneous coronary intervention) within the past 3 months.
7. Stroke within the past 6 months.
8. Bilateral renal artery stenosis or obstructive disorders, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
9. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* SGPT (ALT) or SGOT (AST) \> 2.5 times the upper limit of normal range, or
* Serum creatinine \> 2.3 mg/dL (or \> 203 mol/L)
10. Pre-menopausal women (last menstruation \<=1 year prior to signing informed consent) who:
* Have a positive urine pregnancy test (UPT) prior to randomisation (Visit 2 or Visit 2.1 for subject participating in the clamp procedure)
* Are not surgically sterile, or
* Are nursing, or pregnant, or
* Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study and do not agree to periodic pregnancy testing during participation in the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable or injectable contraceptives and estrogen patch. No exceptions will be made.
11. Hematocrit \< 35%.
12. Primary aldosteronism.
13. Hereditary fructose intolerance.
14. History of drug or alcohol dependency within the previous 6 months.
15. Currently participating in a weight loss program.
16. Any investigational drug therapy within one month of randomisation or during the study.
17. Known hypersensitivity to any component of the study drug (telmisartan or placebo).
18. Any circumstances the Investigator feels participation in the study would hinder subject safety or completion of the study.
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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UCLA School of Medicine- Divison of Endocrinology
Los Angeles, California, United States
University of CA at SanDiego- Department of Endocrinology
San Diego, California, United States
Boehringer Ingelheim Investigational Site
Westlake Village, California, United States
Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
University of Rochester Medical Center
Rochester, New York, United States
Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
Boehringer Ingelheim Investigational Site
Harker Heights, Texas, United States
University of Manitoba, Diabetes Research Group
Winnipeg, Manitoba, Canada
St. Joseph's Health Care London
London, Ontario, Canada
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, Canada
Århus Sygehus
Aarhus C, , Denmark
Universitätsmedizin Berlin
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Künzing, , Germany
Boehringer Ingelheim Investigational Site
Unterschneidheim, , Germany
Policlinico Monteluce
Perugia, , Italy
Azienda Ospedale Università di Pisa
Pisa, , Italy
Countries
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Other Identifiers
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502.469
Identifier Type: -
Identifier Source: org_study_id