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NCT04830462

Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

Completed Phase 4 Last updated 16 May 2023
What this trial tests

Phase 4 trial testing Rifampicin 300 Mg Oral Capsule in Latent Tuberculosis in 32 participants. Completed in 1 May 2023.

Timeline
15 April 2021
Primary endpoint
1 May 2023
1 May 2023

Quick facts

Lead sponsorHerlev and Gentofte Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment32
Start date15 April 2021
Primary completion1 May 2023
Estimated completion1 May 2023
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Herlev and Gentofte Hospital

Who can join

18 and older, any sex, with Latent Tuberculosis or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The impact of an oral glucose load on IFN-γ-release in persons infected with Mycobacterium tuberculosis.
    Lorentsson HJN, Clausen CR, Faurholt-Jepsen D, Hansen KB, et al · · 2024 · PMID 39350021 · DOI 10.1186/s12879-024-09920-x
  2. The effect of Mycobacterium tuberculosis treatment on thrombelastography-assessed haemostasis: a prospective cohort study.
    Lorentsson HJN, Clausen CR, Faurholt-Jepsen D, Hansen KB, et al · · 2024 · PMID 38918780 · DOI 10.1186/s12959-024-00625-4

Verify or expand the search:

Other recruiting trials for Latent Tuberculosis

Currently open trials in the same condition.

Other Herlev and Gentofte Hospital trials

Trials by the same sponsor.

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Data sources for this page

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