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

NCT07651202 | Completed DMC

• 1 other identifier: KY20260413-KS-09
• Study Type: observational
• Target: 5,218
• Locations: 1 country
• Sites: 1

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.

Conditions

HELICOBACTER PYLORI INFECTIONS; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

H. pylori Positive Group

Participants with positive 13C or 14C urea breath test result

Other: 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.

Interventions

No intervention. This is an observational study. OTHER

No intervention. This is an observational study.

H. pylori Negative Group; H. pylori Positive Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)