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Tuberculosis Drug Levels in Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242511
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
London North West Healthcare NHS Trust

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.


Condition or disease Intervention/treatment
Tuberculosis Diabetes Mellitus Diagnostic Test: Measurement of tuberculosis medications level

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Anti-tuberculous Drug Levels in Diabetic and Non-diabetic Tuberculosis Patients
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. TB medication levels [ Time Frame: 2 hours following medication dose ]
    Comparison of 2-hour post-dose levels of anti-tuberculosis medications


Biospecimen Description:
Blood samples will be taken and analysed by high performance liquid chromatograp


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242511


Contacts
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Contact: Jessica Barrett, MBBS MA 07779110992 jessica.barrett5@nhs.net
Contact: Sunder Chita 02088695829 sunderchita@nhs.net

Sponsors and Collaborators
London North West Healthcare NHS Trust
Investigators
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Principal Investigator: Jessica Barrett London North West University Healthcare NHS Trust
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Responsible Party: London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT04242511    
Other Study ID Numbers: v1.0 30/10/2019
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London North West Healthcare NHS Trust:
Tuberculosis
Diabetes
Rifampicin
Therapeutic Drug Monitoring
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections