Endothelial DysfunctionPhase 1PPINCT02022280
Effect of Proton Pump Inhibitors on Endothelial Function
A Phase 1 study testing Lansoprazole in people with Endothelial Dysfunction, run by Stanford University at 1 site in United States.
Trial summary
In this randomized controlled crossover study, the investigators propose to test the hypothesis that proton pump inhibitors (PPIs) increase plasma levels of asymmetric dimethylarginine (ADMA), which is a marker of endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers aged 18 to 75 years (n=10) or male or female volunteers with a history of coronary or peripheral artery disease (n=10)
- Able to understand the nature of the study and to give written informed consent
- Able to communicate well with the investigator himself or his/her representatives
- Body Mass Index between 18 kg/m^2 and 35 kg/m^2 at the screening visit
- Creatinine <1.5, and liver enzymes <2x normal, with all laboratory tests considered normal or of no significant clinical relevance to the study by the investigator
Who cannot join
- Contra-indication to proton pump inhibitor treatment
- Current treatment with PPI or H2 antagonist, and not able to tolerate withdrawal or washout of medication.
- Current or historical evidence of clinically severe cardiovascular, neurological, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolic or psychiatric disease.
- Any other acute or chronic disease which could influence the volunteer's health and/or the study results
- Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or hernia repair
- Use of enzyme inducers or enzyme inhibitor drugs within the last three months before the first drug administration
Show all 13Show fewer
- Participation in another ongoing clinical trial
- Past or current drug exposure amounting to drug abuse or addiction
- Past or current alcohol exposure amounting to alcohol abuse or addiction (i.e. > 28 units per week for males, where 1 unit = one measure of spirit (25 mL), one glass of wine (125 mL) or 1/2 pint beer)
- Donation of blood or any other major blood loss (>500 mL) within three months before the study
- Unwilling or unable to comply with the study protocol for any reason or in the opinion of the investigator should not participate in the study
- Positive test for hepatitis B surface antigen, hepatitis C antibody, HIV-1 or HIV-2 antibody at screening
- Known allergy or intolerance to any other compound in the study drug or any other closely related compound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Proton Pump Inhibitors (PPIs) Increase Cardiovascular Risk? Effect of PPIs on Endothelial Function and ADMA.
In this randomized controlled crossover study, the investigators propose to test the hypothesis that proton pump inhibitors (PPIs) increase plasma levels of asymmetric dimethylarginine (ADMA), which is a marker of endothelial dysfunction. The authors propose to evaluate ADMA concentrations and vascular function analysis in healthy volunteers and adults with a history of cardiovascular disease given PPI vs placebo for four weeks each.
- Conditions
- Endothelial Dysfunction
- Being tested
- Lansoprazole, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Also called Prevacid
PlaceboDrug
Vitamin pill
| Study group | Role | What they receive |
|---|---|---|
| Proton Pump Inhibitor | Experimental | Lansoprazole (Prevacid) Receives: Drug: Lansoprazole |
| Vitamin pill | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reactive hyperemia index as measured by peripheral arterial tonometry (EndoPAT)
Measured: Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks
Secondary outcomes (1)
Change in blood ADMA level
Measured: Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Leeper, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022280
- Sponsor's protocol ID
- 23848
- Other IDs
- 1144447-121-DHAXB
- Acronym
- PPI
- Status last verified
- Aug 2022
- First submitted
- 3 Dec 2013
- Last updated
- 23 Aug 2022
- Results posted
- No
Publications
Ghebremariam YT, Cooke JP, Khan F, Thakker RN, Chang P, Shah NH, Nead KT, Leeper NJ. Proton pump inhibitors and vascular function: A prospective cross-over pilot study. Vasc Med. 2015 Aug;20(4):309-16. doi: 10.1177/1358863X14568444. Epub 2015 Apr 2.
PubMed 25835348
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Proton Pump Inhibitors (PPIs) Increase Cardiovascular Risk? Effect of PPIs on Endothelial Function and ADMA.
- ClinicalTrials.gov ID
- NCT02022280
- Acronym / sponsor ID
- PPI / 23848
- Conditions
- Endothelial Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized controlled crossover study, the investigators propose to test the hypothesis that proton pump inhibitors (PPIs) increase plasma levels of asymmetric dimethylarginine (ADMA), which is a marker of endothelial dysfunction. The authors propose to evaluate ADMA concentrations and vascular function analysis in healthy volunteers and adults with a history of cardiovascular disease given PPI vs placebo for four weeks each.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Pump Inhibitor | Experimental | Drug: LansoprazoleLansoprazole (Prevacid) |
| Vitamin pill | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female volunteers aged 18 to 75 years (n=10) or male or female volunteers with a history of coronary or peripheral artery disease (n=10)
- Able to understand the nature of the study and to give written informed consent
- Able to communicate well with the investigator himself or his/her representatives
- Body Mass Index between 18 kg/m^2 and 35 kg/m^2 at the screening visit
- Creatinine <1.5, and liver enzymes <2x normal, with all laboratory tests considered normal or of no significant clinical relevance to the study by the investigator
Key exclusion criteria (13 listed)
- Contra-indication to proton pump inhibitor treatment
- Current treatment with PPI or H2 antagonist, and not able to tolerate withdrawal or washout of medication.
- Current or historical evidence of clinically severe cardiovascular, neurological, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolic or psychiatric disease.
- Any other acute or chronic disease which could influence the volunteer's health and/or the study results
- Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or hernia repair
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 |
|---|---|---|
| LansoprazoleAlso: Prevacid | Drug | Proton Pump Inhibitor |
| PlaceboVitamin pill | Drug | Vitamin pill |
Primary outcome
Change in reactive hyperemia index as measured by peripheral arterial tonometry (EndoPAT)
Time frame: Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks
1 secondary outcome
Change in blood ADMA level
Time frame: Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Results publication: PubMed 25835348Ghebremariam YT, Cooke JP, Khan F, Thakker RN, Chang P, Shah NH, Nead KT, Leeper NJ. Proton pump inhibitors and vascular function: A prospective cross-over pilot study. Vasc Med. 2015 Aug;20(4):309-16. doi: 10.1177/1358863X14568444. Epub 2015 Apr 2.
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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.
Nicholas Leeper, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lansoprazole in people with Endothelial Dysfunction, run by Stanford 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 5 inclusion and 13 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 23 Aug 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in reactive hyperemia index as measured by peripheral arterial tonometry (EndoPAT) (time frame: Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks). 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 NCT02022280, which also lists 1 linked publication.
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 23 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.