Impact of olmesartan on glucose metabolism in hypertensive patients receiving statin therapy
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0005143
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 82
1. Patients must agree to the study protocol and provide written informed consent
2. Outpatients = 20 years of age, male or female
3. Non-diabetic patients with glucose intolerance (100< fasting glucose <125mg/dL)
4. Hypertensive patients (At screening)
>140/90 mmHg without any antihypertensive drugs
>120/80 mmHg with antihypertensive drugs
5. Hyperlipidemia patients who met the following criteria (At randomization)
1). one cardiovascular risk factor or the 10-year ASCVD risk <10%: LDL >130mg/dL
2). two or more cardiovascular risk factors or the 10-year ASCVD risk >10%: LDL >100mmHg
* Cardiovascular risk factors:
(1) Male >45 years old, Female >55 years old
(2) Family history of premature cardiovascular disease
(first relatives male <55 years old and/or female <65 years old)
(3) HDL <40 mg/dL
(4) Smoker
(5) hypertension (SBP >140/90mmHg or anti-hypertensives user)
1. Known patients with recent acute coronary syndrome within 3 months, myocardial infarction, ischemic stroke, peripheral artery disease, carotid artery disease, abdominal aneurysm or diabetic mellitus (Major atherosclerotic cardiovascular events)
2. Patients receiving treatment that could potentially affect glucose metabolism, including corticosteroids, diuretics, beta-blocker, oral hypoglycemic agents, lipid therapy other than rosuvastatin
3. History of hypersensitivity or allergy to the study drug, drugs of similar chemical classes, or ARB as well as known or suspected contraindications to the study drug
4. Current acute decompensated heart failure or dyspnea of NYHA functional class IV
5. Medical history of hospitalization for heart failure within 6 weeks
6. Substantial myocardial ischemia requiring coronary revascularization or a plan of coronary revascularization within 1 year
7. Symptomatic hypotension and/or a SBP < 100 mmHg at screening
8. Estimated GFR < 30 mL/min/1.73m2
9. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x upper limit of normal (ULN) at the screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of the portacaval shunt.
10. History of severe pulmonary disease
11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a barrier method plus a hormonal method
12. Pregnant or nursing (lactating) women
13. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effect of candesartan versus olmesartan on beta cell function after 16-week treatment.
- Secondary Outcome Measures
Name Time Method The effect of candesartan versus olmesartan on insulin sensitivity;The effect of candesartan versus Olmesartan on fasting plasma glucose, insulin, C-peptide and HbA1c after 16-week treatment;Changes of ACE2 and Ang-(1-7) level from baseline to 16 weeks in each treatment group