Effect of Proton Pump Inhibitors on Endothelial Function

NCT02022280 | Completed Phase 1

• 2 other identifiers: 238481144447-121-DHAXB
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Change in blood ADMA level

  Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks

Study Arms (2)

Proton Pump Inhibitor

EXPERIMENTAL

Lansoprazole (Prevacid)

Drug: Lansoprazole

Vitamin pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lansoprazole DRUG

Also known as: Prevacid

Proton Pump Inhibitor

Placebo DRUG

Vitamin pill

Vitamin pill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 25835348 RESULT

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nicholas Leeper, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 27, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

US (1)