Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2023-05-01

Brief Summary

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This study will be investigating the effect of latent tuberculosis infection (LTBI) treatment on glucose tolerance and low-grade inflammation. Almost a century ago, researchers proposed that diabetes (DM) was associated with increased risk of Tuberculosis infection (TB). A more recent systematic review concluded that DM increases the relative risk for TB 3.1 times. Reversely, TB may affect the glycaemic control; TB is in many cases a chronic infection characterised by long term low-grade inflammation and weight loss, and persons with TB are known to be at risk of hyperglycaemia and DM at time of diagnosis. A latent infection with the m.tuberculosis bacteria is "silent" without symptoms.

1,7 billion have LTBI on a global scale. Event though the infected person does not experience symptoms, increased background inflammation has been shown in LTBI patients in previous studies. We also know that an increase in inflammatory markers precedes clinical development of DM, and that subclinical inflammation contributes to insulin resistance. We hypothesise that LTBI contributes to dysregulated glucose metabolism due to increased low-grade inflammation, and that treatment will reduce low-grade inflammation and improve glucose tolerance.

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Detailed Description

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Conditions

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Latent Tuberculosis Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study consists of two arms with different patient populations. Both arms will receive identical treatment. Arm A will have type 2 diabetes and latent tuberculosis infection (LTBI). Group B will not have any form of diabetes, but LTBI.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LTBI and DM

Participants with LTBI and DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion

Group Type OTHER

Rifampicin 300 Mg Oral Capsule

Intervention Type DRUG

Rifampicin 600 mg orally once daily for 4 months

Isoniazid 300 Mg ORAL TABLET

Intervention Type DRUG

Isoniazid 300 mg daily for 6 months

LTBI without DM

Participants with LTBI without DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion

Group Type OTHER

Rifampicin 300 Mg Oral Capsule

Intervention Type DRUG

Rifampicin 600 mg orally once daily for 4 months

Isoniazid 300 Mg ORAL TABLET

Intervention Type DRUG

Isoniazid 300 mg daily for 6 months

Interventions

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Rifampicin 300 Mg Oral Capsule

Rifampicin 600 mg orally once daily for 4 months

Intervention Type DRUG

Isoniazid 300 Mg ORAL TABLET

Isoniazid 300 mg daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18+ years
* Known DM type 2

* 18+ years
* LTBI positive
* No diagnosis with or known DM (1 and 2)

Exclusion Criteria

* Previous treatment for TB or LTBI
* Pregnancy
* Type 1 DM
* Known immunosuppression such as: HIV, steroid treatment within 14 days before inclusion, daily NSAID treatment, ongoing chemotherapy, ongoing immunomodulating treatment or splenectomy
* Known contraindication to both study drugs
* Known active liver disease
* Known severe inflammatory or rheumatological diseases with immune activation and need for prolonged systemic treatment such as IBD, RA, Psoriasis and Wegners granulomatosis
* Recent antibiotic treatment (\>2 days) or severe infection within 14 days before enrollment
* Known active cancer

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No