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Latent TuberculosisPhase 4NCT04830462

Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

A Phase 4 study testing Rifampicin 300 Mg Oral Capsule and Isoniazid 300 Mg ORAL TABLET in people with Latent Tuberculosis and Diabetes Mellitus, Type 2, run by Herlev and Gentofte Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rifampicin 300 Mg Oral Capsule and Isoniazid 300 Mg ORAL TABLET
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteDenmark
Study dates
15 Apr 2021to 1 May 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18+ years
  • Known DM type 2
  • 18+ years
  • LTBI positive
  • No diagnosis with or known DM (1 and 2)

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • Herlev-Gentofte Hospital

    Copenhagen

Other trials in Denmark

About this study

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.

Being tested
Rifampicin 300 Mg Oral Capsule, Isoniazid 300 Mg ORAL TABLET
Keywords
low-grade inflammation, glucose metabolism, body composition, cytokines, adipokines, biomarkers
Medical subject headings
Latent Tuberculosis, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rifampicin 300 Mg Oral CapsuleDrug

    Rifampicin 600 mg orally once daily for 4 months

  • Isoniazid 300 Mg ORAL TABLETDrug

    Isoniazid 300 mg daily for 6 months

Study groups in NCT04830462
Study groupRoleWhat they receive
LTBI and DMOtherParticipants with LTBI and DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion
Receives: Drug: Rifampicin 300 Mg Oral Capsule; Drug: Isoniazid 300 Mg ORAL TABLET
LTBI without DMOtherParticipants with LTBI without DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion
Receives: Drug: Rifampicin 300 Mg Oral Capsule; Drug: Isoniazid 300 Mg ORAL TABLET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OGTT (oral glucose tolerance test)

    Reduction in plasma glucose area under the curve during OGTT

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

Secondary outcomes (5)

  1. Changes in insulin production

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

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

  2. Changes in insulin resistance

    HOMA-IR pre and post treatment

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

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

    A panel of cytokines and adipokines

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

  4. INF-gamma change

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

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

  5. Changes in body composition

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start15 Apr 2021
  3. Primary completion1 May 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04830462
Sponsor's protocol ID
H-20028894 or 126496
Status last verified
May 2023
First submitted
31 Mar 2021
Last updated
16 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39350021

  • 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.

    PubMed 38918780

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rifampicin 300 Mg Oral Capsule and Isoniazid 300 Mg ORAL TABLET in people with Latent Tuberculosis and Diabetes Mellitus, Type 2, run by Herlev and Gentofte Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OGTT (oral glucose tolerance test) (time frame: Time Frame: 4-6 months (depending on treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04830462, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.

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Clinical Trial NCT04830462 | AzTrials