Treatment of latent tuberculosis - Evaluation of the effect on sugar metabolism and inflammatio

Phase 1

• Conditions: latent tuberculosis infection; MedDRA version: 20.0Level: PTClassification code 10065048Term: Latent tuberculosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-001173-69-DK
• Lead Sponsor: Pernille Ravn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-22
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

5: Inclusion and exclusion criteria:
5.a: Inclusion criteria group A
•18+ years
•Known DM type 2
5.b: Inclusion criteria group B
•18+ years
•LTBI positive
•No diagnosis with or known DM (1 and 2)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

5.c: Exclusion criteria group A and B
•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 RIF and INH
•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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We propose that DM or impaired glucose tolerance in persons with latent tuberculosis infection( LTBI), is driven by LTBI induced chronic low-grade inflammation. Eradication of LTBI should therefore improve glucose metabolism and reduce chronic inflammation biomarkers. <br><br>The objectives of the present study are to determine if eradication of LTBI will:<br><br>I.Improve glucose tolerance<br>;Secondary Objective: The objectives of the present study are to determine if eradication of LTBI will:<br><br>II.Reduce markers of low-grade inflammation;Primary end point(s): Primary endpoint: <br>•Change in glucose tolerance<br>;Timepoint(s) of evaluation of this end point: Subjects treated with RIF:<br>OGTTs will be performed at the start of the treatment phase +-7 days, and at week 16 +- 7 days. <br><br>Subjects treated with INH:<br>OGTTs will be performed at the start of the treatment phase +-7 days, and at week 24 +- 7 days. <br><br>Results will be evaluated at the end of trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints:<br>•Changes in insulin production <br>•Changes in insulin resistance<br>•Changes in low-grade inflammation<br>•Changes in microRNA (miRNA) expression<br>•Changes in QFT <br>•Changes in body composition<br><br>;Timepoint(s) of evaluation of this end point: Subjects treated with RIF:<br>Blood samples will be drawn at the start of the treatment phase +-7 days, at 8 weeks +-7 days after the start of the treatment phase, and at 19 weeks +- 7 days.<br><br>Subjects treated with INH:<br>Blood samples will be drawn at the start of the treatment phase +-7 days, at 12 weeks +-7 days after the start of the treatment phase, and at 27 weeks +- 7 days. <br><br>Results will be evaluated at the end of trial<br>