TuberculosisNCT04242511
Tuberculosis Drug Levels in Diabetics
An observational study of Tuberculosis and Diabetes Mellitus, run by London North West Healthcare NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Diabetes Mellitus
- What is being tested?
- Measurement of tuberculosis medications level
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- May 2021to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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%.
Who may be able to join
- 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
Who cannot join
- Subject aged under 18 years
- Inability to give informed consent
- Repeat HbA1c level <48mmol/mol
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Anti-tuberculous Drug Levels in Diabetic and Non-diabetic Tuberculosis Patients
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.
Read the detailed description
This is a case-controlled study measuring tuberculosis medication levels in diabetic and non-diabetic patients on treatment for tuberculosis.
Case:
Our tuberculosis clinic checks the levels of glycosalated haemoglobin (HbA1c), a marker of diabetes, in all patients with a new diagnosis of tuberculosis before they start treatment. All patients who are either known to have diabetes or have a raised HbA1c level will be identified at their clinic appointment. Patients who have a raised HbA1c and are not known to have diabetes will have a repeat blood test to confirm the result as part of normal clinical practice. If their level is still raised or they are known to have diabetes they will be asked if they wish to participate in the study.
They will be provided with a patient information leaflet and given the opportunity to ask questions, and discuss with friends and family if preferred.
If they agree to participate their tuberculosis care will continue as usual. Part of the standard care for our TB patients is to have blood tests at 2 weeks, 4 weeks and 8 weeks after starting treatment, to check for toxicity from the medications.
They will be asked to take their TB medications as usual on the morning of their scheduled blood tests.
To confirm the time at which they took their doses they will be asked to either take a time-stamped video of themselves taking their morning tablets, or to text or call the study co-ordinator when they take their tablets. They will then be asked to come in for the blood test 2 hours later. Prior to the blood test their consent will be confirmed and they will be given the opportunity to ask questions or withdraw from the study. Along with the routine blood tests (to check full blood count, liver and kidney functions) a further sample will be taken to check levels of the TB medications.
They will also have their weight checked, and be asked if their other medications (eg for diabetes) have changed since their first clinic appointment.
If they are known to have abdominal tuberculosis, or are suspected to have other problems with absorbing food and medications, they will be asked to stay for a second blood test between 0 and 8 hours after they took their medication. This will help identify the peak medication level more accurately if absorption from the gut is delayed.
A small number of the diabetic patients may also be asked to inform the study co-ordinator when they take their anti-diabetic medications so that the study blood sample can also be used to measure the levels of their anti-diabetic medications.
The blood samples for the routine tests will be processed by the hospital pathology lab as usual. Study blood samples will be spun to separate the serum which contains the medications. The serum will then be frozen at -20C, prior to being processed in batches using High Performance Liquid Chromatography.
If the participant agrees the same procedure will be carried out at their 4 and 8 week routine blood tests.
Controls:
Controls will be recruited from TB clinic in a similar way to cases. Patients who have an HbA1c level <48 mmol/mol and no history of diabetes will be reviewed to see if they meet the eligibility criteria. This will include assessing whether they are in the same weight category (5kg bands e.g. 50-54kg, 55-59kg, 60-64kg etc) as recruited diabetic patients. If they consent to participate then they will be asked to follow the same study protocol as the diabetic cases, as detailed above.
- Conditions
- Tuberculosis, Diabetes Mellitus
- Being tested
- Measurement of tuberculosis medications level
- Keywords
- Tuberculosis, Diabetes, Rifampicin, Therapeutic Drug Monitoring
- Medical subject headings
- Tuberculosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of tuberculosis medications levelDiagnostic test
Measurement of tuberculosis medication levels at 2 hours post-dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Measurement of tuberculosis medications level | |
| Controls | Tuberculosis patients without diabetes mellitus:
1), 2), 3) as above 4) IFCC HbA1c level < 48mmol/mol 5) Weight matched to cases (+/- 2kg) Receives: Diagnostic Test: Measurement of tuberculosis medications level |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB medication levels
Comparison of 2-hour post-dose levels of anti-tuberculosis medications
Measured: 2 hours following medication dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startMay 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Barrett, Principal investigator, LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242511
- Sponsor's protocol ID
- v1.0 30/10/2019
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-tuberculous Drug Levels in Diabetic and Non-diabetic Tuberculosis Patients
- ClinicalTrials.gov ID
- NCT04242511
- Acronym / sponsor ID
- v1.0 30/10/2019
- Conditions
- Tuberculosis, Diabetes Mellitus
- Keywords
- Tuberculosis, Diabetes, Rifampicin, Therapeutic Drug Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a case-controlled study measuring tuberculosis medication levels in diabetic and non-diabetic patients on treatment for tuberculosis.
Case:
Our tuberculosis clinic checks the levels of glycosalated haemoglobin (HbA1c), a marker of diabetes, in all patients with a new diagnosis of tuberculosis before they start treatment. All patients who are either known to have diabetes or have a raised HbA1c level will be identified at their clinic appointment. Patients who have a raised HbA1c and are not known to have diabetes will have a repeat blood test to confirm the result as part of normal clinical practice. If their level is still raised or they are known to have diabetes they will be asked if they wish to participate in the study.
They will be provided with a patient information leaflet and given the opportunity to ask questions, and discuss with friends and family if preferred.
If they agree to participate their tuberculosis care will continue as usual. Part of the standard care for our TB patients is to have blood tests at 2 weeks, 4 weeks and 8 weeks after starting treatment, to check for toxicity from the medications.
They will be asked to take their TB medications as usual on the morning of their scheduled blood tests.
To confirm the time at which they took their doses they will be asked to either take a time-stamped video of themselves taking their morning tablets, or to text or call the study co-ordinator when they take their tablets. They will then be asked to come in for the blood test 2 hours later. Prior to the blood test their consent will be confirmed and they will be given the opportunity to ask questions or withdraw from the study. Along with the routine blood tests (to check full blood count, liver and kidney functions) a further sample will be taken to check levels of the TB medications.
They will also have their weight checked, and be asked if their other medications (eg for diabetes) have changed since their first clinic appointment.
If they are known to have abdominal tuberculosis, or are suspected to have other problems with absorbing food and medications, they will be asked to stay for a second blood test between 0 and 8 hours after they took their medication. This will help identify the peak medication level more accurately if absorption from the gut is delayed.
A small number of the diabetic patients may also be asked to inform the study co-ordinator when they take their anti-diabetic medications so that the study blood sample can also be used to measure the levels of their anti-diabetic medications.
The blood samples for the routine tests will be processed by the hospital pathology lab as usual. Study blood samples will be spun to separate the serum which contains the medications. The serum will then be frozen at -20C, prior to being processed in batches using High Performance Liquid Chromatography.
If the participant agrees the same procedure will be carried out at their 4 and 8 week routine blood tests.
Controls:
Controls will be recruited from TB clinic in a similar way to cases. Patients who have an HbA1c level <48 mmol/mol and no history of diabetes will be reviewed to see if they meet the eligibility criteria. This will include assessing whether they are in the same weight category (5kg bands e.g. 50-54kg, 55-59kg, 60-64kg etc) as recruited diabetic patients. If they consent to participate then they will be asked to follow the same study protocol as the diabetic cases, as detailed above.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Measurement of tuberculosis medications levelTuberculosis 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 | – | Diagnostic Test: Measurement of tuberculosis medications levelTuberculosis patients without diabetes mellitus: 1), 2), 3) as above 4) IFCC HbA1c level < 48mmol/mol 5) Weight matched to cases (+/- 2kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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%.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Subject aged under 18 years
- Inability to give informed consent
- Repeat HbA1c level <48mmol/mol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of tuberculosis medications levelMeasurement of tuberculosis medication levels at 2 hours post-dose | Diagnostic test | Cases, Controls |
Primary outcome
TB medication levels
Time frame: 2 hours following medication dose
Comparison of 2-hour post-dose levels of anti-tuberculosis medications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Barrett principal investigator
LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Diabetes Mellitus, run by London North West Healthcare NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Barrett, MBBS MA (07779110992, jessica.barrett5@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB medication levels (time frame: 2 hours following medication dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.