Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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 sub-clinical 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.
Status | Not yet recruiting |
Enrollment | 220 |
Est. completion date | May 2023 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Herlev and Gentofte Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | OGTT (oral glucose tolerance test) | Reduction in plasma glucose area under the curve during OGTT | 4-6 months (depending on treatment) | |
Secondary | Changes in insulin production | Insulin/c-peptid, HOMA-B pre and post treatment | 4-6 months (depending on treatment) | |
Secondary | Changes in insulin resistance | HOMA-IR pre and post treatment | 4-6 months (depending on treatment) | |
Secondary | Changes in low-grade inflammatory markers and in adipokines | A panel of cytokines and adipokes | 4-6 months (depending on treatment) | |
Secondary | INF-gamma change | Changes in IFN-? levels after incubation with saline solution, TB antigen or phytohemagglutinin A Pre, during and post treatment | 4-6 months (depending on treatment) | |
Secondary | Changes in body composition | Body composition pre and post treatment measured with DEXA-scanning | 4-6 months (depending on treatment) |
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