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

Impact of LTBI treatment on glucose tolerance and chronic inflammation

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001173-69-DK

Enrollment

220

Registered

2020-04-22

Start date

2020-10-22

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

latent tuberculosis infection MedDRA version: 20.0 Level: PT Classification code 10065048 Term: Latent tuberculosis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Rimactan Pharmaceutical Form: Capsule, hard INN or Proposed INN: RIFAMPICIN CAS Number: 13292-46-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. The objectives of the present study are to determine if eradication of LTBI will: I. Improve glucose tolerance ;Secondary Objective: The objectives of the present study are to determine if eradication of LTBI will: II. Reduce markers of low-grade inflammation;Primary end point(s): Primary endpoint: • Change in glucose tolerance ;Timepoint(s) of evaluation of this end point: Subjects treated with RIF: OGTTs will be performed at the start of the treatment phase +-7 days, and at week 16 +- 7 days. Subjects treated with INH: OGTTs will be performed at the start of the treatment phase +-7 days, and at week 24 +- 7 days. Results will be evaluated at the end of trial	—

Measure

Time frame

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. The objectives of the present study are to determine if eradication of LTBI will: I. Improve glucose tolerance ;Secondary Objective: The objectives of the present study are to determine if eradication of LTBI will: II. Reduce markers of low-grade inflammation;Primary end point(s): Primary endpoint: • Change in glucose tolerance ;Timepoint(s) of evaluation of this end point: Subjects treated with RIF: OGTTs will be performed at the start of the treatment phase +-7 days, and at week 16 +- 7 days. Subjects treated with INH: OGTTs will be performed at the start of the treatment phase +-7 days, and at week 24 +- 7 days. Results will be evaluated at the end of trial

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: • Changes in insulin production • Changes in insulin resistance • Changes in low-grade inflammation • Changes in microRNA (miRNA) expression • Changes in QFT • Changes in body composition ;Timepoint(s) of evaluation of this end point: Subjects treated with RIF: 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. Subjects treated with INH: 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. Results will be evaluated at the end of trial	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: • Changes in insulin production • Changes in insulin resistance • Changes in low-grade inflammation • Changes in microRNA (miRNA) expression • Changes in QFT • Changes in body composition ;Timepoint(s) of evaluation of this end point: Subjects treated with RIF: 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. Subjects treated with INH: 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. Results will be evaluated at the end of trial

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Countries

Denmark

Contacts

Public Contactlungemedicinsk ambulatorie

gentofte hospital

004538673867

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026