HypertensionNCT01413542

Pharmacogenetics of Ace Inhibitor-Associated Angioedema

A study testing Sitagliptin (DPP4 inhibitor), Substance P, and bradykinin in people with Hypertension and Diabetes Type 2, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension, Diabetes Type 2
What is being tested?: Sitagliptin (DPP4 inhibitor), Substance P, and bradykinin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Nov 2011to Jul 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 21Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University- General Clinic Research Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

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

Read the 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
Being tested: Sitagliptin (DPP4 inhibitor), Substance P,, bradykinin, enalaprilat (ACE inhibitor), Glucagon-like peptide 1
Keywords: DPPIV inhibitors, ACE inhibitors, Bradykinin, glucagon-like peptide (GLP-1), BNP, diabetes, hypertension
Medical subject headings: Hypertension, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01413542
Study group	Role	What they receive
Placebo then sitagliptin (DPP4 inhibition) group 1	Placebo comparator	The effect of vehicle and enalaprilat on the forearm blood flow and t-PA responses to bradykinin and substance P are studied after administration of placebo or sitagliptin (DPP4 inhibition). Receives: Drug: Sitagliptin (DPP4 inhibitor); Drug: Substance P,; Drug: bradykinin; Drug: enalaprilat (ACE inhibitor)
Sitagliptin (DPP4 inhibition) then placebo group 1	Placebo comparator	The effect of vehicle and enalaprilat (ACE inhibition) on the forearm blood flow and t-PA responses to substance P and bradykinin are studied after administration of sitagliptin (DPP4 inhibition) or placebo Receives: Drug: Sitagliptin (DPP4 inhibitor); Drug: Substance P,; Drug: bradykinin; Drug: enalaprilat (ACE inhibitor)
Placebo then sitagliptin group 2	Placebo comparator	The effect of vehicle and enalaprilat (ACE inhibition) on the forearm blood flow and t-PA responses to glucagon-like peptide-1 and brain natriuretic pepdie are studied after administration of placebo or sitagliptin (DPP4 inhibition). Receives: Drug: Sitagliptin (DPP4 inhibitor); Drug: Glucagon-like peptide 1; Drug: brain natriuretic peptide
Sitagliptin (DPP4 inhibition) then comparator group 2	Placebo comparator	The effect of vehicle and enalaprilat on the forearm blood flow and t-PA responses to glucagon-like peptide and brain natriuretic peptide are studied after administration of placebo or sitagliptin (DPP4 inhibition). Receives: Drug: Sitagliptin (DPP4 inhibitor); Drug: Glucagon-like peptide 1; Drug: brain natriuretic peptide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 outcomes (4)

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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Jul 2014

First posted10 Aug 2011 (estimated)
Study startNov 2011
Primary completionJul 2013
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01413542
Sponsor's protocol ID: HL079184
Status last verified: Oct 2015
First submitted: 8 Aug 2011
Last updated: 4 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Devin JK, Pretorius M, Nian H, Yu C, Billings FT 4th, Brown NJ. Dipeptidyl-peptidase 4 inhibition and the vascular effects of glucagon-like peptide-1 and brain natriuretic peptide in the human forearm. J Am Heart Assoc. 2014 Aug 26;3(4):e001075. doi: 10.1161/JAHA.114.001075.
PubMed 25158865
Devin JK, Pretorius M, Nian H, Yu C, Billings FT 4th, Brown NJ. Substance P increases sympathetic activity during combined angiotensin-converting enzyme and dipeptidyl peptidase-4 inhibition. Hypertension. 2014 May;63(5):951-7. doi: 10.1161/HYPERTENSIONAHA.113.02767. Epub 2014 Feb 10.
PubMed 24516103

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacogenetics of Ace Inhibitor-Associated Angioedema:Aim 1
ClinicalTrials.gov ID: NCT01413542
Acronym / sponsor ID: HL079184
Conditions: Hypertension, Diabetes Type 2
Keywords: DPPIV inhibitors, ACE inhibitors, Bradykinin, glucagon-like peptide (GLP-1), BNP, diabetes, hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Study start: Nov 2011
Primary completion: Jul 2013 (actual)
Study completion: Jul 2014 (actual)
First posted: 10 Aug 2011 (estimated)
Results: Posted 4 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo then sitagliptin (DPP4 inhibition) group 1	Placebo comparator	Drug: Sitagliptin (DPP4 inhibitor), Drug: Substance P,, Drug: bradykinin, Drug: enalaprilat (ACE inhibitor)The effect of vehicle and enalaprilat on the forearm blood flow and t-PA responses to bradykinin and substance P are studied after administration of placebo or sitagliptin (DPP4 inhibition).
Sitagliptin (DPP4 inhibition) then placebo group 1	Placebo comparator	Drug: Sitagliptin (DPP4 inhibitor), Drug: Substance P,, Drug: bradykinin, Drug: enalaprilat (ACE inhibitor)The effect of vehicle and enalaprilat (ACE inhibition) on the forearm blood flow and t-PA responses to substance P and bradykinin are studied after administration of sitagliptin (DPP4 inhibition) or placebo
Placebo then sitagliptin group 2	Placebo comparator	Drug: Sitagliptin (DPP4 inhibitor), Drug: Glucagon-like peptide 1, Drug: brain natriuretic peptideThe effect of vehicle and enalaprilat (ACE inhibition) on the forearm blood flow and t-PA responses to glucagon-like peptide-1 and brain natriuretic pepdie are studied after administration of placebo or sitagliptin (DPP4 inhibition).
Sitagliptin (DPP4 inhibition) then comparator group 2	Placebo comparator	Drug: Sitagliptin (DPP4 inhibitor), Drug: Glucagon-like peptide 1, Drug: brain natriuretic peptideThe effect of vehicle and enalaprilat on the forearm blood flow and t-PA responses to glucagon-like peptide and brain natriuretic peptide are studied after administration of placebo or sitagliptin (DPP4 inhibition).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18 to 65 inclusive
Men and women
Black and White Americans
BMI <25
Postmenopausal status for at least 1 year

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sitagliptin (DPP4 inhibitor)Also: JanuviaSitagliptin 200 mg (DPP4 inhibitor) or matching placebo will be given one hour prior to intra-arterial infusions	Drug	Placebo then sitagliptin (DPP4 inhibition) group 1, Placebo then sitagliptin group 2, Sitagliptin (DPP4 inhibition) then comparator group 2, Sitagliptin (DPP4 inhibition) then placebo group 1
Substance P,Substance P intra-brachial artery (2,4,8 pmol/min)	Drug	Placebo then sitagliptin (DPP4 inhibition) group 1, Sitagliptin (DPP4 inhibition) then placebo group 1
bradykininbradykinin intra-brachial artery (23.6, 47.2, and 94.3 pmol/min)	Drug	Placebo then sitagliptin (DPP4 inhibition) group 1, Sitagliptin (DPP4 inhibition) then placebo group 1
enalaprilat (ACE inhibitor)Also: vasotecintra-brachial artery(0.33 µg/min per 100 mL forearm volume)	Drug	Placebo then sitagliptin (DPP4 inhibition) group 1, Sitagliptin (DPP4 inhibition) then placebo group 1
Glucagon-like peptide 1Also: GLP-1intra-brachial artery (0.45-3.60 pmol/min)	Drug	Placebo then sitagliptin group 2, Sitagliptin (DPP4 inhibition) then comparator group 2
brain natriuretic peptideAlso: nesiritideIntra-brachial artery (0.90, 1.80 and 3.6 pmol/min)	Drug	Placebo then sitagliptin group 2, Sitagliptin (DPP4 inhibition) then comparator group 2

Primary outcome

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).
Time frame: 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
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.

4 secondary outcomes

Assess Tissue Type Plasminogen Activator (tPA) Release
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 4 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Then Sitagliptin (DPP4 Inhibibition)=Group 1	6	5
Sitagliptin (DPP4 Inhibition) Then Placebo=Group 1	6	6
Placebo Then Sitagliptin (DPP4 Inhibition)=Group 2	9	6
Sitagliptin (DPP4 Inhibition) Then Placebo = Group 2	8	7

Primary outcome: 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).

Time frame: 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. Mean (95% Confidence Interval). Unit: estimate of difference(ml/min/100ml FBF)

Measure	Group 1 n = 12	Group 2 n = 17
Effect ACE inhibition on FBF response to Peptide 1	6.5 (4.0 to 9.0)	NA (NA to NA)
Effect DPP4 inhibition on FBF Response to Peptide1	0.2 (-2.4 to 2.7)	-5.0 (-11.6 to 1.6)
Effect ACE/DPP4 inhibit on FBF response Peptide 1	5.9 (3.3 to 8.4)	NA (NA to NA)
Effect DPP4/ACEinhib vs. ACEinhib (FBF to Pep1)	-0.6 (-3.1 to 1.9)	NA (NA to NA)
Effect DPP4/ACEinhib vs. DPP4inhib (FBF to Pep1)	5.7 (3.2 to 8.2)	NA (NA to NA)
Effect ACE inhibition on FBF response to Peptide 2	0.8 (-0.3 to 2.0)	NA (NA to NA)
Effect DPP4 inhibition on FBF response to Peptide2	0.1 (-0.1 to 1.3)	-3.2 (-37.4 to 31.0)
Effect ACE/DPP4 inhibition on Peptide 2 FBF	0.6 (-0.6 to 1.7)	NA (NA to NA)

Group 1 vs Group 2: p <0.001, Mixed Models Analysis

Population analysed: In Group 1: Peptide 1=Max dose Bradykinin; Peptide 2=Substance P (SP) In Group 2: Peptide 1=GLP-1; Peptide 2=BNP (FBF expressed as percent change for both peptides) ACE inhibition=enalaprilat DPP4 inhibition=sitagliptin

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (Placebo Arm)	0 of 12 (0%)	3 of 12 (25%)	Not reported
Group 1 (Sitagliptin Arm)	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
Group 2 (Placebo Arm)	0 of 16 (0%)	3 of 16 (18.8%)	Not reported
Group 2 (Sitagliptin Arm)	1 of 14 (7.1%)	1 of 14 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25158865Devin JK, Pretorius M, Nian H, Yu C, Billings FT 4th, Brown NJ. Dipeptidyl-peptidase 4 inhibition and the vascular effects of glucagon-like peptide-1 and brain natriuretic peptide in the human forearm. J Am Heart Assoc. 2014 Aug 26;3(4):e001075. doi: 10.1161/JAHA.114.001075.
Derived from this study: PubMed 24516103Devin JK, Pretorius M, Nian H, Yu C, Billings FT 4th, Brown NJ. Substance P increases sympathetic activity during combined angiotensin-converting enzyme and dipeptidyl peptidase-4 inhibition. Hypertension. 2014 May;63(5):951-7. doi: 10.1161/HYPERTENSIONAHA.113.02767. Epub 2014 Feb 10.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy J Brown, MD principal investigator

Vanderbilt University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sitagliptin (DPP4 inhibitor), Substance P, and bradykinin in people with Hypertension and Diabetes Type 2, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01413542, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.