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Pharmacogenetics of Ace Inhibitor-Associated Angioedema

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Diabetes Type 2

Intervention: Sitagliptin (Drug); Substance P, (Drug); bradykinin (Drug); enalaprilat (Drug); Glucagon-like peptide 1 (Drug); brain natriuretic peptide (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Nancy J Brown, MD, Principal Investigator, Affiliation: Vanderbilt University

Overall contact:
Stacy Glibert, RN, Phone: 615-322-2105, Email: Stacy.gilbert@vanderbilt.edu

Summary

The investigators would like to find out if sitagliptin, a drug to treat diabetes, affects blood vessel relaxation in healthy people receiving enalapril, a blood pressure medicine. Understanding how these drugs interact in healthy people will help us learn their potential effects in people who have diabetes.

Clinical Details

Official title: Pharmacogenetics of Ace Inhibitor-Associated Angioedema:Aim 1

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The effect of enalaprilat, sitagliptin, or the combination on the vasodilator response (forearm blood flow) to substance P and bradykinin (Group 1) or glucagon like peptide-1 and brain naturetic peptide (Group 2).

Secondary outcome: Assess peptide concentrations, nitric oxide metabolites, tissue type plasminogen activator, glucose, and catecholamines

Detailed description: To test the hypothesis that DPPIV inhibition potentiates the vasodilator response to substance P in the presence of ACE inhibition and to BNP and GLP-1 even in the presence of ACE inhibition. The aim promises to provide important new data regarding the mechanism of action of DPPIV inhibitors and interactive effects of these two drug classes used in a growing population of diabetic patients.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Stacy Glibert, RN, Phone: 615-322-2105, Email: Stacy.gilbert@vanderbilt.edu

Vanderbilt University- General Clinic Research Center, Nashville, Tennessee 37232, United States; Recruiting
Additional Information

Starting date: November 2011
Last updated: June 16, 2013

Page last updated: August 23, 2015

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