H. 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.

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Key information

Conditions

HELICOBACTER PYLORI INFECTIONS Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥18 years
Completed annual health examination at Nanjing First Hospital Health Management Center between May 1, 2024 and May 1, 2025
Underwent 13C or 14C urea breath test for H. pylori status assessment
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
No missing data on key study variables

Exclusion criteria

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

Treatment and study plan

No intervention. This is an observational study.

Other

No intervention. This is an observational study.

Primary outcomes

Prevalence of Metabolic Syndrome

Time frame: Baseline

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.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Jun 16, 2026
Registry last updated: Jun 16, 2026

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.

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