Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830462
• Other study ID #: H-20028894 or 126496
• Status: Completed
• Phase: Phase 4
• Start date: April 15, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Inflammation
• Latent Tuberculosis
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Herlev-Gentofte Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OGTT (oral glucose tolerance test)	Reduction in plasma glucose area under the curve during OGTT	Time Frame: 4-6 months (depending on treatment)
Secondary	Changes in insulin production	Insulin/c-peptid, HOMA-B pre and post treatment	Time Frame: 4-6 months (depending on treatment)
Secondary	Changes in insulin resistance	HOMA-IR pre and post treatment	Time Frame: 4-6 months (depending on treatment)
Secondary	Changes in low-grade inflammatory markers and in adipokines	A panel of cytokines and adipokines	Time Frame: 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	Time Frame: 4-6 months (depending on treatment)
Secondary	Changes in body composition	Body composition pre and post treatment measured with DEXA-scanning and/or bioimpedance	Time Frame: 4-6 months (depending on treatment)