Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04242511 |
| Other study ID # |
v1.0 30/10/2019 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2021 |
| Est. completion date |
May 2022 |
Study information
| Verified date |
March 2021 |
| Source |
London North West Healthcare NHS Trust |
| Contact |
Jessica Barrett, MBBS MA |
| Phone |
07779110992 |
| Email |
jessica.barrett5[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
