Skip to main content
OpenTrials
Completed

NCT Number: NCT02022280

Effect of Proton Pump Inhibitors on Endothelial Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/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

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

Treatment and study plan

Lansoprazole

Drug

Other names: Prevacid

Placebo

Drug

Vitamin pill

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in blood ADMA level

    Time frame: Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Do Proton Pump Inhibitors (PPIs) Increase Cardiovascular Risk? Effect of PPIs on Endothelial Function and ADMA.

Acronym: PPI

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 27, 2013
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.