Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

• Status: Recruiting
• Trial end date: 2023-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herlev and Gentofte Hospital
• Treatments: Isoniazid; Rifampin

Criteria

Inclusion Criteria:

Inclusion criteria for the LTBIDM arm:

• 18+ years

• Known DM type 2

Inclusion criteria for LTBI arm

• 18+ years

• LTBI positive

• No diagnosis with or known DM (1 and 2)

Exclusion Criteria (both arms) :

• 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 inflammatory or rheumatological diseases with immune activation such as IBD, RA, Psoriasis and Wegners granulomatosis

• Recent antibiotic treatment (>2 days) or severe infection within 14 days before enrollment

• Known active cancer