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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTBI and DM | Other | Participants with LTBI and DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion |
|
| LTBI without DM | Other | Participants with LTBI without DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampicin 300 Mg Oral Capsule | Drug | Rifampicin 600 mg orally once daily for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| OGTT (oral glucose tolerance test) | Reduction in plasma glucose area under the curve during OGTT | Time Frame: 4-6 months (depending on treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in insulin production | Insulin/c-peptid, HOMA-B pre and post treatment | Time Frame: 4-6 months (depending on treatment) |
| Changes in insulin resistance | HOMA-IR pre and post treatment |
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Inclusion Criteria:
Inclusion criteria for the LTBIDM arm:
Inclusion criteria for LTBI arm
Exclusion Criteria (both arms) :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev-Gentofte Hospital | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39350021 | Derived | Lorentsson HJN, Clausen CR, Faurholt-Jepsen D, Hansen KB, Ritz C, Jensen SG, Rasmussen EM, Jorgensen A, Lillebaek T, Knop F, Ravn P. The impact of an oral glucose load on IFN-gamma-release in persons infected with Mycobacterium tuberculosis. BMC Infect Dis. 2024 Sep 30;24(1):1079. doi: 10.1186/s12879-024-09920-x. | |
| 38918780 | Derived |
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| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| D007538 | Isoniazid |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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| Isoniazid 300 Mg ORAL TABLET | Drug | Isoniazid 300 mg daily for 6 months |
|
| Time Frame: 4-6 months (depending on treatment) |
| Changes in low-grade inflammatory markers and in adipokines | A panel of cytokines and adipokines | Time Frame: 4-6 months (depending on treatment) |
| INF-gamma change | Changes in IFN-γ levels after incubation with saline solution, TB antigen or phytohemagglutinin A Pre, during and post treatment | Time Frame: 4-6 months (depending on treatment) |
| Changes in body composition | Body composition pre and post treatment measured with DEXA-scanning and/or bioimpedance | Time Frame: 4-6 months (depending on treatment) |
| Lorentsson HJN, Clausen CR, Faurholt-Jepsen D, Hansen KB, Jensen SG, Krogh-Madsen R, Hagelqvist PG, Johansson PI, Vilsboll T, Knop FK, Ravn P. The effect of Mycobacterium tuberculosis treatment on thrombelastography-assessed haemostasis: a prospective cohort study. Thromb J. 2024 Jun 26;22(1):54. doi: 10.1186/s12959-024-00625-4. |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |