Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

Herlev and Gentofte Hospital

Status and phase: Completed; Phase 4

Conditions: Latent Tuberculosis; Diabetes Mellitus, Type 2

Treatments: Drug: Rifampicin 300 Mg Oral Capsule; Drug: Isoniazid 300 Mg ORAL TABLET

Study type: Interventional

Funder types: Other

Identifiers

NCT04830462

H-20028894 or 126496

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

LTBI and DM

Other group

Description:

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

Treatment:

Drug: Rifampicin 300 Mg Oral Capsule

Drug: Isoniazid 300 Mg ORAL TABLET

LTBI without DM

Other group

Description:

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

Treatment:

Drug: Rifampicin 300 Mg Oral Capsule

Drug: Isoniazid 300 Mg ORAL TABLET