H. Pylori Infection and Metabolic Syndrome: A Retrospective Cross-Sectional Study

Association Between Helicobacter Pylori Infection and Metabolic Syndrome: A Retrospective Cross-Sectional Study

This retrospective cross-sectional study evaluates the association between Helicobacter pylori infection and metabolic syndrome using health examination data from 5,218 adults at Nanjing First Hospital. Participants are divided into H. pylori-positive and negative groups based on urea breath test results. The primary outcome is metabolic syndrome prevalence (CDS 2020 criteria). Multivariable logistic regression will be used to assess the independent association, with subgroup analyses by age and sex.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: Other: No intervention. This is an observational study.

• Study Type: Observational
• Enrollment (Actual): 5218

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital, Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) who completed annual health examinations at Nanjing First Hospital between May 1, 2024 and May 1, 2025, with complete data on H. pylori breath testing and metabolic syndrome components (waist circumference, blood pressure, fasting glucose, triglycerides, HDL-cholesterol). Pregnant/lactating women and those with severe organ dysfunction or malignancy were excluded.

Description

Inclusion Criteria:

1. Age ≥18 years
2. Completed annual health examination at Nanjing First Hospital Health Management Center between May 1, 2024 and May 1, 2025
3. Underwent 13C or 14C urea breath test for H. pylori status assessment
4. Complete data on the following measurements: height, weight, waist circumference, systolic blood pressure, diastolic blood pressure, fasting blood glucose, triglycerides, and high-density lipoprotein cholesterol
5. No missing data on key study variables

Exclusion Criteria:

1. Missing key data on H. pylori test results (13C or 14C urea breath test)
2. Missing any of the following primary metabolic indicators: waist circumference, blood pressure (systolic/diastolic), fasting blood glucose, triglycerides, or HDL-cholesterol
3. Pregnancy or lactation
4. History of severe liver dysfunction
5. History of severe kidney dysfunction
6. History of malignancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
H. pylori Positive Group; Participants with positive 13C or 14C urea breath test result	Other: No intervention. This is an observational study.; No intervention. This is an observational study.
H. pylori Negative Group; Participants with negative 13C or 14C urea breath test result	Other: No intervention. This is an observational study.; No intervention. This is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Metabolic Syndrome	Metabolic syndrome is defined according to the Chinese Diabetes Society (CDS) 2020 criteria. Participants meeting three or more of the following five criteria are classified as having metabolic syndrome: (1) central obesity: waist circumference ≥90 cm in males or ≥85 cm in females; (2) hyperglycemia: fasting blood glucose ≥6.1 mmol/L or previously diagnosed diabetes on treatment; (3) hypertension: blood pressure ≥130/85 mmHg or previously diagnosed hypertension on treatment; (4) hypertriglyceridemia: fasting triglycerides ≥1.70 mmol/L; (5) low HDL-cholesterol: fasting HDL-cholesterol <1.04 mmol/L.	Baseline

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome
• Other Study ID Numbers: KY20260413-KS-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No