NCT01413542

Pharmacogenetics of Ace Inhibitor-Associated Angioedema

Pharmacogenetics of Ace Inhibitor-Associated Angioedema:Aim 1

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 (angiotensin converting enzyme or ACE inhibition), a blood pressure medicine. Understanding how these drugs interact in healthy people will help us learn their potential effects in people who have diabetes.

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 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.

Conditions

• Hypertension
• Diabetes Type 2

Interventions

Type	Name	Description
DRUG	Sitagliptin (DPP4 inhibitor)	Sitagliptin 200 mg (DPP4 inhibitor) or matching placebo will be given one hour prior to intra-arterial infusions
DRUG	Substance P,	Substance P intra-brachial artery (2,4,8 pmol/min)
DRUG	bradykinin	bradykinin intra-brachial artery (23.6, 47.2, and 94.3 pmol/min)
DRUG	enalaprilat (ACE inhibitor)	intra-brachial artery(0.33 µg/min per 100 mL forearm volume)
DRUG	Glucagon-like peptide 1	intra-brachial artery (0.45-3.60 pmol/min)
DRUG	brain natriuretic peptide	Intra-brachial artery (0.90, 1.80 and 3.6 pmol/min)

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-07-01
• Completion: 2014-07-01
• First posted: 2011-08-10
• Last updated: 2015-11-04
• Results posted: 2015-11-04

Locations

1 site across 1 country: United States