Clinical trial NCT04830462: Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
Official title: Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Latent Tuberculosis
Diabetes Mellitus, Type 2
Keywords: low-grade inflammation
glucose metabolism
body composition
cytokines
adipokines
biomarkers
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: OGTT (oral glucose tolerance test)
timeFrame: Time Frame: 4-6 months (depending on treatment)
Secondary outcomes:
measure: Changes in insulin production
timeFrame: Time Frame: 4-6 months (depending on treatment)
measure: Changes in insulin resistance
timeFrame: Time Frame: 4-6 months (depending on treatment)
measure: Changes in low-grade inflammatory markers and in adipokines
timeFrame: Time Frame: 4-6 months (depending on treatment)
measure: INF-gamma change
timeFrame: Time Frame: 4-6 months (depending on treatment)
measure: Changes in body composition
timeFrame: Time Frame: 4-6 months (depending on treatment)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev-Gentofte Hospital
Study officials:
References: