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NCT04830462
Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
Phase 4 trial testing Rifampicin 300 Mg Oral Capsule in Latent Tuberculosis in 32 participants. Completed in 1 May 2023.
1 May 2023
Quick facts
| Lead sponsor | Herlev and Gentofte Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 32 |
| Start date | 15 April 2021 |
| Primary completion | 1 May 2023 |
| Estimated completion | 1 May 2023 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Rifampicin 300 Mg Oral Capsule — full drug profile →
- Isoniazid 300 Mg ORAL TABLET
Conditions studied
- Latent Tuberculosis — all drugs for Latent Tuberculosis →
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Herlev and Gentofte Hospital
Who can join
18 and older, any sex, with Latent Tuberculosis or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The impact of an oral glucose load on IFN-γ-release in persons infected with Mycobacterium tuberculosis.
Lorentsson HJN, Clausen CR, Faurholt-Jepsen D, Hansen KB, et al · · 2024 · PMID 39350021 · DOI 10.1186/s12879-024-09920-x -
The effect of Mycobacterium tuberculosis treatment on thrombelastography-assessed haemostasis: a prospective cohort study.
Lorentsson HJN, Clausen CR, Faurholt-Jepsen D, Hansen KB, et al · · 2024 · PMID 38918780 · DOI 10.1186/s12959-024-00625-4
Verify or expand the search:
- PubMed search for NCT04830462
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Latent Tuberculosis
Currently open trials in the same condition.
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- NCT05411744 — One-month Latent Tuberculosis Treatment for Renal Transplant Candidates · Phase 4 · active not recruiting
- NCT05412212 — Brief Educational Video for Patients Prescribed LTBI Treatment · NA · active not recruiting
- NCT05022862 — Economic Incentives and vDOT for Latent Tuberculosis Infection · NA · recruiting
Other Herlev and Gentofte Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04830462 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Herlev and Gentofte Hospital
- Last refreshed: 16 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04830462.
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