Latent Tuberculosis in Type 2 Diabetes

Directly Observed Preventive Therapy (DOPT) for Latent Tuberculosis Infection Patients With Poorly Controlled Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06874725

Acronym

Enrollment

552

Registered

2025-03-13

Start date

2018-04-18

Completion date

2025-04-18

Last updated

2025-03-13

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

Conditions

Latent Tuberculosis Infection

Keywords

Latent tuberculosis infection, diabetes, observational study

Brief summary

The patients with poorly controlled DM underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.

Detailed description

Poor control of diabetes mellitus (DM) increases active tuberculosis (TB) risk. Understanding risk factors for latent TB infection (LTBI) in this population is crucial for policy making. Under a collaborative multidisciplinary team consisting of endocrinologists and pulmonologists, patients with poorly controlled DM were enrolled; these patients underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.

Interventions

DRUGRifapentine and Isoniazid for 3 months

tuberculosis preventive therapy (TPT) with 3 months of weekly rifapentine plus isoniazid (3HP)

DRUGIsoniazid (INH) daily for 9 months

tuberculosis preventive therapy (TPT) with 9 months of daily isoniazid (9H)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* aged ≥45 years * poorly controlled DM (pDM), defined as HbA1c ≥9% within the preceding year

Exclusion criteria

* active TB * immunocompromise (use of immunosuppressors * current pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Brain-Derived Neurotrophic Factor	9 months	Biomarker

Secondary

Measure	Time frame	Description
Inflammatory markers	9 months	aryl hydrocarbon receptor, adhesion molecules, dickkopf-related protein 1

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026