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NCT Number: NCT02324218

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases Virus Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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
  • Inclusion criteria will be assessed for each calendar year between the Years 2000 and 2012.

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.

Treatment and study plan

Data Collection

Other

Data extraction from CPRD database of UK.

Primary outcomes

  1. Occurrence of new HepB diagnosis among patients between 0-80 years of age previously diagnosed with DM, between 2000 and 2012, in the UK CPRD or Hospital Episodes Statistics (HES).

    Time frame: Up to 12 years

  2. Occurrence of new HepB diagnosis among non-DM patients between 0-80 years of age, in the UK CPRD or HES.

    Time frame: Up to 12 years

Secondary outcomes

  1. Hospitalisation episode recorded in HES due to HepB infection or complications among patients between 0-80 years of age previously diagnosed with DM and in DM-free (non-DM) patients, in the UK, for whom CPRD-HES linkage is available.

    Time frame: Up to 12 years

  2. All cause mortality among HepB cases in the DM and DM-free (non-DM) patients between 0-80 years of age, in the UK.

    Time frame: Up to 12 years

  3. HepB cause-specific mortality among DM and DM-free (non-DM) patients between 0-80 years of age, in the UK for whom CPRD-ONS mortality linkage is available.

    Time frame: Up to 12 years

  4. New-onset or prevalent HepB diagnosis among new-onset or prevalent DM and DM-free (non-DM) patients between 0-80 years of age, in the UK, regardless of the onset of HepB in relation to the diagnosis of DM.

    Time frame: Up to 12 years

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Incidence of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age, in the United Kingdom Clinical Practice Research Datalink (CPRD)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2014
Registry last updated
Jul 19, 2016

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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