| Trial ID: | L5463 |
| Source ID: | NCT01413542
|
| Associated Drug: |
Sitagliptin (Dpp4 Inhibitor)
|
| Title: |
Pharmacogenetics of Ace Inhibitor-Associated Angioedema
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01413542/results
|
| Conditions: |
Hypertension|Diabetes Type 2
|
| Interventions: |
DRUG: Sitagliptin (DPP4 inhibitor)|DRUG: Substance P,|DRUG: bradykinin|DRUG: enalaprilat (ACE inhibitor)|DRUG: Glucagon-like peptide 1|DRUG: brain natriuretic peptide
|
| Outcome Measures: |
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)., Forearm blood flow (FBF) was measured by strain gauge plethysmography at the completion of each dose of intra-arterial peptide. A dose response curve was therefore constructed for each vasoactive peptide substrate. The effect of sitagliptin (DPP4 inhibition) vs. placebo and enalaprilat (ACE inhibition) vs. vehicle on the forearm blood flow response to each peptide could then be determined., 60 minutes post-placebo or sitagliptin (DPP4 inhibition) and over last 2 minutes of each 5 min infusion per peptide dose (30 min washout between peptides); sequence repeated with enalaprilat (ACE inhibition) or vehicle | Secondary: Assess Tissue Type Plasminogen Activator (tPA) Release, Following measurement of FBF, samples will be obtained to determine the effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) (group 1), Blood for analysis of tPA release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)|Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP), Heart rate was measured every 5 minutes throughout the study day (and thus during each dose of peptide infusion)|Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP), Blood for analysis of norepinephrine (NE) release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)|Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion, Blood for analysis of GLP-1 levels was obtained one hour after sitagliptin (DPP4 inhibition) vs. placebo administration and after each dose of GLP-1
|
| Sponsor/Collaborators: |
Sponsor: Vanderbilt University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-11
|
| Completion Date: |
2014-07
|
| Results First Posted: |
2015-11-04
|
| Last Update Posted: |
2015-11-04
|
| Locations: |
Vanderbilt University- General Clinic Research Center, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01413542
|
