Tuberculosis Drug Levels in Diabetics
Comparison of Anti-tuberculous Drug Levels in Diabetic and Non-diabetic Tuberculosis Patients
1 other identifier
observational
48
0 countries
N/A
Brief Summary
This study compares blood levels of tuberculosis medications between diabetic patients and non-diabetic patients. There is some research that suggests these medications are at lower levels in diabetic patients with tuberculosis, and this could adversely affect the outcome of their infection. Diabetic patients are at higher risk of dying or having a severe episode of tuberculosis therefore it is important that their care is optimised as far as possible. To answer the research question all participants in the study will have an extra blood sample drawn at the same time as their routine blood tests which are used to monitor their tuberculosis treatment. Some participants will have additional blood samples taken at different times to give a more accurate picture of the medication levels in their bloodstream. The study will be conducted in the tuberculosis clinics at London North West University Healthcare NHS Trust and will include adult patients with and without diabetes who have recently been diagnosed with tuberculosis. Some other information about their routine medications, weight and height, and severity of diabetes will also be collected, to see if these affect the medication levels in the bloodstream as well.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedApril 15, 2021
March 1, 2021
7 months
January 23, 2020
April 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TB medication levels
Comparison of 2-hour post-dose levels of anti-tuberculosis medications
2 hours following medication dose
Study Arms (2)
Cases
Tuberculosis patients with diabetes mellitus: 1. Subject aged 18 years of age or over 2. Written, informed consent obtained. 3. New diagnosis of tuberculosis and started on anti-tuberculosis treatment 4. Known diagnosis of diabetes or two consecutive raised IFCC HbA1c levels (\>= 48 mmol/mol) at the time of TB diagnosis
Controls
Tuberculosis patients without diabetes mellitus: 1), 2), 3) as above 4) IFCC HbA1c level \< 48mmol/mol 5) Weight matched to cases (+/- 2kg)
Interventions
Measurement of tuberculosis medication levels at 2 hours post-dose
Eligibility Criteria
This study will be conducted in the tuberculosis clinics at London North West University Healthcare NHS Trust. The study participants will be recruited from patients with a diagnosis of tuberculosis, with and without diabetes. Diabetes is a common comorbidity in tuberculosis patients in this area, with a prevalence of around 15 to 20%.
You may qualify if:
- Subject aged 18 years of age or over
- Written, informed consent obtained.
- New diagnosis of tuberculosis and started on anti-tuberculosis treatment Cases: Known diagnosis of diabetes or two consecutive raised IFCC HbA1c levels (\>= 48 mmol/mol) at the time of TB diagnosis Controls: IFCC HbA1c level \< 48mmol/mol
You may not qualify if:
- Subject aged under 18 years
- Inability to give informed consent
- Repeat HbA1c level \<48mmol/mol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Blood samples will be taken and analysed by high performance liquid chromatograp
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Barrett
LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2020
First Posted
January 27, 2020
Study Start
May 1, 2021
Primary Completion
December 1, 2021
Study Completion
May 1, 2022
Last Updated
April 15, 2021
Record last verified: 2021-03