Status:

UNKNOWN

Tuberculosis Drug Levels and Continuous Glucose Monitoring in Diabetic Patients

Lead Sponsor:

London North West Healthcare NHS Trust

Conditions:

Tuberculosis

Diabetes Mellitus

Eligibility:

All Genders

18+ years

Brief Summary

Diabetes significantly increases the risk of developing active tuberculosis (TB). Diabetic patients who do develop TB have worse treatment outcomes and overall mortality. TB also worsens blood glucose...

Detailed Description

This study has been designed as a case control trial analysed via population pharmacokinetic modelling, with the hypothesis that overall exposure to TB medications will be lower in the diabetic than t...

Eligibility Criteria

Inclusion

  • Cases:
  • Subject aged 18 years of age or over
  • Written, informed consent obtained.
  • New diagnosis of tuberculosis and starting on anti-tuberculosis treatment
  • Known diagnosis of diabetes or a raised IFCC HbA1c level (\>= 48 mmol/mol) at the time of TB diagnosis
  • Controls:
  • Subject aged 18 years of age or over
  • Written, informed consent obtained.
  • New diagnosis of tuberculosis and starting on anti-tuberculosis treatment
  • IFCC HbA1c level \< 48mmol/mol and no known diagnosis of diabetes

Exclusion

  • Subject aged under 18 years
  • Inability to give informed consent

Key Trial Info

Start Date :

February 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2024

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT05329415

Start Date

February 1 2022

End Date

May 1 2024

Last Update

June 7 2023

Active Locations (1)

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London North West University NHS University Trust

London, United Kingdom, HA1 3UJ