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Completed

NCT Number: NCT04830462

Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

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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Key information

Conditions

Latent Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Gram-Positive Bacterial Infections Infections Latent Infection Metabolic Diseases Mycobacterium Infections Nutritional and Metabolic Diseases Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Herlev-Gentofte Hospital

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifampicin 300 Mg Oral Capsule

Drug

Rifampicin 600 mg orally once daily for 4 months

Isoniazid 300 Mg ORAL TABLET

Drug

Isoniazid 300 mg daily for 6 months

Primary outcomes

  1. OGTT (oral glucose tolerance test)

    Time frame: Time Frame: 4-6 months (depending on treatment)

    Reduction in plasma glucose area under the curve during OGTT

Secondary outcomes

  1. Changes in insulin production

    Time frame: Time Frame: 4-6 months (depending on treatment)

    Insulin/c-peptid, HOMA-B pre and post treatment

  2. Changes in insulin resistance

    Time frame: Time Frame: 4-6 months (depending on treatment)

    HOMA-IR pre and post treatment

  3. Changes in low-grade inflammatory markers and in adipokines

    Time frame: Time Frame: 4-6 months (depending on treatment)

    A panel of cytokines and adipokines

  4. INF-gamma change

    Time frame: Time Frame: 4-6 months (depending on treatment)

    Changes in IFN-γ levels after incubation with saline solution, TB antigen or phytohemagglutinin A Pre, during and post treatment

  5. Changes in body composition

    Time frame: Time Frame: 4-6 months (depending on treatment)

    Body composition pre and post treatment measured with DEXA-scanning and/or bioimpedance

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2021
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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