Effect of Sitagliptin and an ACE Inhibitor on Blood Pressure in Metabolic Syndrome

Exclusion Criteria

• •Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater or the use of anti-diabetic medication
• •History of reported or recorded hypoglycemia (plasma glucose less than 70 mg/dL)
• •Use of hormone replacement therapy
• •In hypertensive patients, a seated systolic blood pressure greater than 179 mmHg or a seated diastolic blood pressure greater than 110 mmHg
• •Pregnancy
• •Breast-feeding
• •Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
• •Treatment with anticoagulants
• •History of serious neurological disease such as cerebral hemorrhage, stroke, or transient ischemic attack
• •History or presence of immunological or hematological disorders
• •Diagnosis of current asthma
• •History of angioedema associated with use of ACE-I
• •Clinically significant gastrointestinal impairment that could interfere with drug absorption
• •Impaired hepatic function (aspartate amino transaminase \[AST\] and/or alanine amino transferase \[ALT\] \> 2.0 x upper limit of normal range)
• •Impaired renal function (serum creatinine \> 1.5 mg/dl)
• •Hematocrit \<35%
• •Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
• •Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
• •Treatment with lithium salts
• •History of alcohol or drug abuse
• •Treatment with any investigational drug in the 1 month preceding the study
• •Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
• •Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
• •Oral contraceptives