N/A
N=29
Pharmacogenetics of Ace Inhibitor-Associated Angioedema
Hypertension · Diabetes Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01413542 ↗Enrolled (actual)
29
Serious AEs
1.9%
Results posted
Nov 2015
Primary outcome: Primary: The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2). — 6.5; NA; 0.2; -5.0 estimate of difference(ml/min/100ml FBF) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sitagliptin (DPP4 inhibitor) (Drug); Substance P, (Drug); bradykinin (Drug); enalaprilat (ACE inhibitor) (Drug); Glucagon-like peptide 1 (Drug); brain natriuretic peptide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2). |
6.5; NA; 0.2; -5.0; 5.9; NA | <0.001 sig |
| SECONDARY Assess Tissue Type Plasminogen Activator (tPA) Release |
118.6; 145.5; 1.6; 12.9; 90.9; 132.1 | 0.02 sig |
| SECONDARY Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP) |
-1.8; 2.55; 0.45; 4.55 | 0.011 sig |
| SECONDARY Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP) |
-43.18; -52.18; -37.27; 23.45 | 0.05 |
| SECONDARY Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion |
5.13; 15.44; 5.39; 30.63 | 0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 65 inclusive
- Men and women
- Black and White Americans
- BMI 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
Data sourced from ClinicalTrials.gov (NCT01413542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.