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PPI: Effect of Proton Pump Inhibitors on Endothelial Function

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT02022280
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
14
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Do Proton Pump Inhibitors (PPIs) Increase Cardiovascular Risk? Effect of PPIs on Endothelial Function and ADMA.
Actual Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Proton Pump Inhibitor

Lansoprazole (Prevacid)

Drug: Lansoprazole
Other Names:
  • Prevacid

    		•
    Placebo Comparator: Vitamin pill

    Drug: Placebo
    Vitamin pill

    Outcome Measures

    Primary Outcome Measures

    1. Change in reactive hyperemia index as measured by peripheral arterial tonometry (EndoPAT) [Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks]

    Secondary Outcome Measures

    1. Change in blood ADMA level [Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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/m2 and 35 kg/m2 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

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Nicholas Leeper, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT02022280
    Other Study ID Numbers:
    • 23848
    • 1144447-121-DHAXB
    First Posted:
    Dec 27, 2013
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of Aug 23, 2022