The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.

Condition	Intervention	Phase
Indication 1:Obesity Indication 2:Insulin Resistance	Drug: MICARDIS® (telmisartan)	Phase II

Further Study Details: 

Primary Outcomes: 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).
Secondary Outcomes: from baseline: Glucose disposal rates; Insulin sensitivity(IS) index as Rd/I (clamp); IS index (OGTT- min model); Insulin secretion capacity; fasting insulin & gluc; AUC gluc & insulin; ratio of AUCglucose ÷ by AUCinsulin; lipids; & inflam markers
Expected Total Enrollment:  120

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA

1. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
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

1. 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.
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:

   1. SGPT (ALT) or SGOT (AST) >2.5 times the upper limit of normal range, or
   2. Serum creatinine >2.3 mg/dL (or >203 ?mol/L).

10. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:

    1. have a positive urine pregnancy test (UPT) prior to randomisation (Visit 2 or Visit 2.1 for subject participating in the clamp procedure)
    2. are not surgically sterile, or
    3. are nursing, or pregnant, or
    4. 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00146289

Susann Tierney, Ms.      +1 (203) 798-9988  Ext. 7788    stierney@rdg.boehringer-ingelheim.com

California
      UCLA School of Medicine- Divison of Endocrinology, Los Angeles,  California,  United States; Recruiting
      University of CA at SanDiego- Department of Endocrinology, San Diego,  California,  United States; Recruiting
      Westlake Medical Research, Westlake Village,  California,  United States; Recruiting
Illinois
      Chicago,  Illinois,  United States; Recruiting
New York
      University of Rochester Medical Center, Rochester,  New York,  United States; Recruiting
Ohio
      Sterling Research Group, Cincinnati,  Ohio,  United States; Recruiting
Tennessee
      Clinical Research Associates, Inc., Nashville,  Tennessee,  United States; Recruiting
Texas
      Team Research of Texas, Harker Heights,  Texas,  United States; Recruiting
Canada, Manitoba
      Diabetes Research Group, Winnipeg,  Manitoba,  Canada; Recruiting
Canada, Ontario
      St. Joseph''''s Health Care London, London,  Ontario,  Canada; Recruiting
      Ottawa Health Research Institute and University of Ottawa, Ottawa,  Ontario,  Canada; Recruiting
Denmark
      Århus Sygehus, Aarhus C,  Denmark; No longer recruiting
Germany, -
      Facharzt für Allgemeinmedizin, Unterschneidheim,  -,  Germany; Recruiting
      Fachärztin für Innere Medizin, Künzing,  -,  Germany; Recruiting
      Universitätsmedizin Berlin, Berlin,  -,  Germany; Recruiting
Italy
      Policlinico Monteluce, Perugia,  Italy; No longer recruiting
      Azienda Ospedale Università di Pisa, Pisa,  Italy; No longer recruiting

Study chairs or principal investigators

Susann Tierney, Ms.,  Study Chair,  Boehringer Ingelheim Pharmaceuticals   

Study ID Numbers:  502.469
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00146289
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13