H. Pylori Infection and AIP Levels (HP-AIP)

December 25, 2025 updated by: Nahla Ahmed Khalaf, Tanta University

Helicobacter Pylori Infection as A Potential Risk Factor for Dyslipidemia: Insights From Atherogenic Index of Plasma (AIP)

Helicobacter pylori is a common bacterial infection of the stomach that can cause ulcers and other digestive problems. Recent studies suggest that this infection may also affect metabolism and blood fats (lipids), which are important for heart health. Changes in lipid levels, such as higher triglycerides and lower "good" cholesterol (HDL), can increase the risk of cardiovascular disease.

This study will examine whether H. pylori infection is linked to changes in lipid profiles, especially the Atherogenic Index of Plasma (AIP). AIP is a calculation based on triglycerides and HDL cholesterol that helps predict the risk of heart disease.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tanta, Egypt
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult patients (≥18 years) attending the Gastroenterology Unit at Tanta University Hospitals (Egypt) and the Internal Medicine Department at Tadawi Hospital (Saudi Arabia). Participants will include both men and women diagnosed with or without H. pylori infection, recruited consecutively during routine clinical visits.

Description

Inclusion Criteria:

  • Patients older than 18 years.
  • Able to sign the written consent.
  • Willing to participate in the research and undergo H. pylori testing. Exclusion criteria
  • Unwilling to participate in the study.
  • History of severe metabolic disorders.
  • Taking medications that affect adipose tissue metabolism.
  • History of gastric surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1A: H. pylori Positive - Normal AIP Group 1B: H. pylori Positive - Elevated AIP Group 2: H.

Participants will undergo a urea breath test to confirm H. pylori infection status.

Fasting blood samples will be collected to measure triglycerides and HDL cholesterol, and the Atherogenic Index of Plasma (AIP) will be calculated.

Group 1A: H. pylori Positive - Normal AIP, 1B: H. pylori Positive - Elevated AIP, Group 2: H.

Participants will undergo a urea breath test to confirm H. pylori infection status.

Fasting blood samples will be collected to measure triglycerides and HDL cholesterol, and the Atherogenic Index of Plasma (AIP) will be calculated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atherogenic Index of Plasma (AIP)
Time Frame: Baseline (single fasting blood sample at enrollment).
AIP is calculated as log10(triglycerides/HDL cholesterol).
Baseline (single fasting blood sample at enrollment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

February 18, 2025

Study Completion (Actual)

August 4, 2025

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Helicobacter Pylori and AIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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