A Comparison of the Effect of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on the Ability of Overweight Patients With High Blood Pressure to Respond to Insulin

Study Overview
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Brief Summary
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To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.

Official Title
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The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension

Conditions
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Hypertension, Insulin Resistance, Metabolic Syndrome

Intervention / Treatment
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* Drug: Olmesartan medoxomil
* Drug: Losartan potassium
* Drug: Atenolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18 and 75 years (inclusive) Willingness to undergo insulin clamp procedure twice Overweight or obese (BMI=25-39 kg/m2) Subject must meet one of the following two blood pressure criteria at week-2 and at week-1: Systolic blood pressure 140-179 mmHg and diastolic blood pressure 85-99 mmHg OR Systolic blood pressure < 140 mmHg and diastolic blood pressure 90-99 mmHg If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study Exclusion Criteria: Systolic blood pressure > 179 mmHg Diastolic blood pressure > 99 mmHg or < 85 mmHg Diagnosis of diabetes mellitus History of myocardial infraction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, unstable angina pectoris or an episode of heart failure requiring hospitalization Previous history of a cerebrovascular accident or a transient ischemic attack History of allergic response to atenolol, losartan potassium, olmesartan medoxomil or any of their components Any serious disorder, including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data Laboratory abnormalities that could compromise subject safety

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olmesartan medoxomil|nan|
|Drug: Losartan potassium|nan|
|Drug: Atenolol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity |  |  | 
| -To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity |  |  |