NCT04830462

Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Latent Tuberculosis
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Rifampicin 300 Mg Oral Capsule	Rifampicin 600 mg orally once daily for 4 months
DRUG	Isoniazid 300 Mg ORAL TABLET	Isoniazid 300 mg daily for 6 months

Timeline

• Start date: 2021-04-15
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2021-04-05
• Last updated: 2023-05-16

Locations

1 site across 1 country: Denmark