Association Between Helicobacter Pylori Infection and Metabolic Syndrome: A Retrospective Cross-Sectional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5,218
- Locations
- 1
- Primary Endpoint
- Prevalence of Metabolic Syndrome
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
H. pylori Positive Group
Participants with positive 13C or 14C urea breath test result
Intervention: No intervention. This is an observational study. (Other)
H. pylori Negative Group
Participants with negative 13C or 14C urea breath test result
Intervention: No intervention. This is an observational study. (Other)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported