Status:
COMPLETED
Pharmacogenetics of Ace Inhibitor-Associated Angioedema
Lead Sponsor:
Vanderbilt University
Conditions:
Hypertension
Diabetes Type 2
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4 inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people receiving enalapril (an...
Detailed Description
To test the hypothesis that DPPIV inhibition with sitagliptin potentiates the vasodilator response to substance P in the presence of ACE inhibition with enalaprilat and to BNP and GLP-1 even in the pr...
Eligibility Criteria
Inclusion
- Age 18 to 65 inclusive
- Men and women
- Black and White Americans
- BMI \<25
- For female subjects:
- Postmenopausal status for at least 1 year
- Status post surgical sterilization
- If childbearing potential, utilization of a barrier method of birth control and willingness to undergo blood B-hcg testing prior to drug treatment and on every study day
Exclusion
- Smoking
- Diabetes type 1 or 2, as defined by a fasting glucose of 126 mg/dl or greater or the use of anti-diabetic medication
- Hypertension as defined by an untreated seated SBP greater than 140 mmHg an untreated DBP greater than 90 mmHg or the use of antihypertensives
- History of reported or recorded hypoglycemia (plasma glucose less than 70 mg/dl)
- Pregnancy
- Breast-feeding
- Use of hormone replacement therapy
- The use of contraceptive therapy
- Use of any medication other than multivitamin
- Hematocrit \<35%
- Cardiovascular disease such as history of myocardial infarction, 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
- Asthma
- History of angioedema
- History of cough or other side effect during ACE inhibitor use
- Impaired renal function, as defined by an eGFR\<60ml/min/1.73M2
- Clinically significant gastrointestinal impairment that could interfere with drug absorption
- Impaired hepatic function (aspartate amino transaminase\[AST\] and/or alanine amino transferase \[ALT\]\>2 x upper limit of normal range
- 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 to follow-up visits, and the unlikelihood of completing the study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01413542
Start Date
November 1 2011
End Date
July 1 2014
Last Update
November 4 2015
Active Locations (1)
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1
Vanderbilt University- General Clinic Research Center
Nashville, Tennessee, United States, 37232