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Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

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ClinicalTrials.gov Identifier: NCT04830462
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Niklas Lorentsson, Herlev and Gentofte Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Latent Tuberculosis Diabetes Mellitus, Type 2 Drug: Rifampicin 300 Mg Oral Capsule Drug: Isoniazid 300 Mg ORAL TABLET Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : April 15, 2023
Estimated Study Completion Date : May 15, 2023

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830462


Contacts
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Contact: Niklas Lorentsson, MD 31617979 hans.johan.niklas.lorentsson.02@regionh.dk
Contact: Pernille Ravn, ass.Prof pernille.ravn.02@regionh.dk

Locations
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Denmark
Herlev-Gentofte Hospital Recruiting
Copenhagen, Denmark
Contact: Niklas Lorentsson, MD    31617979    hans.johan.niklas.lorentsson.02@regionh.dk   
Contact: Pernille Ravn, ass.Prof       pernille.ravn.02@regionh.dk   
Sponsors and Collaborators
Herlev and Gentofte Hospital
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Responsible Party: Niklas Lorentsson, MD, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT04830462    
Other Study ID Numbers: H-20028894 or 126496
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Niklas Lorentsson, Herlev and Gentofte Hospital:
low-grade inflammation
glucose metabolism
body composition
cytokines
adipokines
biomarkers
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Diabetes Mellitus, Type 2
Inflammation
Pathologic Processes
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rifampin
Isoniazid
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Fatty Acid Synthesis Inhibitors