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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04428294
Other study ID # 126496
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 2020
Est. completion date May 2023

Study information

Verified date June 2020
Source Herlev and Gentofte Hospital
Contact Niklas Lorentsson, MD
Phone 31 61 79 79
Email niklas_lorentzon@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Rifampicin 300 Mg Oral Capsule
Rifampicin 600 mg orally once daily for 4 months
Isoniazid 300 MG
Isoniazid 300 mg daily for 6 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Herlev and Gentofte Hospital

Outcome

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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