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
Phase 4
Completed
- Conditions
- Metabolic SyndromeHypertensionInsulin Resistance
- Registration Number
- NCT00185094
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
- Secondary Outcome Measures
Name Time Method -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