This Study Aims to Determine the Incidence, of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age

NCT ID: NCT02324218

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 161429 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-01-31

Brief Summary

This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large population-based cohort in United Kingdom (UK) using data from the CPRD database.

Detailed Description

The study is a retrospective, observational, descriptive, cohort study, in DM and non-DM patients of 0-80 years of age. As a first step the eligible baseline population from CPRD will be defined as per the data quality qualifiers, which include subjects aged 0-80 years, "acceptable for research" registered in practices classified as "up to standard" by the CPRD for the time period 2000- 2012. The following cohorts will be defined from the baseline population:

• DM cohort: Patients diagnosed with type 1 or type 2 DM, as confirmed by diagnosis medical codes with or without a DM related drug or monitoring devices prescription.
• Non-DM cohort: Patients with the absence of personal history of DM diagnosis or antidiabetic drug or monitoring devices prescriptions.

From the above defined cohorts, HepB cases will be identified based on clinical diagnosis codes, Hospital Episodes Statistics (HES) or positive diagnostic laboratory tests results.

Conditions

Hepatitis B

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Diabetes mellitus Group

All the subjects with diabetes mellitus diagnosed with hepatitis B, reported in the CPRD database of UK, from the Year 2000 to 2012.

Data collection

Intervention Type: OTHER

Data extraction from CPRD database of UK.

Non-Diabetes mellitus Group

All the subjects with hepatitis B who are diagnosed negative diabetes mellitus, reported in the CPRD database of UK, from the Year 2000 to 2012.

Data collection

Intervention Type: OTHER

Data extraction from CPRD database of UK.

Interventions

Data collection

Data extraction from CPRD database of UK.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects, 0 to 80 years of age during the study period.
• Subjects acceptable for research as per CPRD definition:

• Acceptable flag for research.
• Subjects with at least 12 months of observation time at the time of inclusion in the study:

• Subjects have to be registered in the CPRD database for at least 12 months at the date of inclusion in the study.
• Subjects have to be registered in a general practitioner practice classified as 'up to standard' for at least 12 months at the date of inclusion in the study.
• Particular Case of New Born Children.

• To ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in CPRD.
• Inclusion Date

Exclusion Criteria

• For the analyses requiring the inclusion of HES data, HES records linked with more than one CPRD patient will be excluded from the analyses.

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Ferreira GLC, Marano C, De Moerlooze L, Guignard A, Feng Y, El Hahi Y, van Staa T. Incidence and prevalence of hepatitis B in patients with diabetes mellitus in the UK: A population-based cohort study using the UK Clinical Practice Research Datalink. J Viral Hepat. 2018 May;25(5):571-580. doi: 10.1111/jvh.12841. Epub 2018 Jan 17.

Reference Type: DERIVED

PMID: 29220868 (View on PubMed)

Other Identifiers

14_114

Identifier Type: OTHER

Identifier Source: secondary_id

201335

Identifier Type: -

Identifier Source: org_study_id