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Active, Not Recruiting

NCT Number: NCT06874725

Latent Tuberculosis in Type 2 Diabetes

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Latent Tuberculosis Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Metabolic Diseases Mycobacterium Infections Nutritional and Metabolic Diseases Tuberculosis

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifapentine and Isoniazid for 3 months

Drug

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

Other names: 3HP

Isoniazid (INH) daily for 9 months

Drug

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

Other names: 9H

Primary outcomes

  1. Brain-Derived Neurotrophic Factor

    Time frame: 9 months

    Biomarker

Secondary outcomes

  1. Inflammatory markers

    Time frame: 9 months

    aryl hydrocarbon receptor, adhesion molecules, dickkopf-related protein 1

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Acronym: TB

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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