Clinical trial NCT00185094: 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
Official title: The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Insulin Resistance
Metabolic Syndrome
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
Secondary outcomes:
measure: -To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity
measure: -To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: San Diego
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References: