Tuberculosis Drug Levels in Diabetics

April 14, 2021 updated by: London North West Healthcare NHS Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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%.

Description

Inclusion Criteria:

  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 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

Exclusion Criteria:

  1. Subject aged under 18 years
  2. Inability to give informed consent
  3. Repeat HbA1c level <48mmol/mol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Diagnostic test: Measurement of tuberculosis medications level
Measurement of tuberculosis medication levels at 2 hours post-dose
Controls

Tuberculosis patients without diabetes mellitus:

1), 2), 3) as above 4) IFCC HbA1c level < 48mmol/mol 5) Weight matched to cases (+/- 2kg)
Diagnostic test: Measurement of tuberculosis medications level
Measurement of tuberculosis medication levels at 2 hours post-dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
TB medication levels
Time Frame: 2 hours following medication dose
Comparison of 2-hour post-dose levels of anti-tuberculosis medications
2 hours following medication dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
London North West Healthcare NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Barrett, London North West University Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • v1.0 30/10/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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