Latent Tuberculosis in Type 2 Diabetes (TB)

March 8, 2025 updated by: Taichung Veterans General Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

552

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407219
        • Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 months of weekly rifapentine plus isoniazid
Drug: Rifapentine and Isoniazid for 3 months
tuberculosis preventive therapy (TPT) with 3 months of weekly rifapentine plus isoniazid (3HP)
Other Names:
  • 3HP
Active Comparator: 9 months of daily isoniazid
Drug: Isoniazid (INH) daily for 9 months
tuberculosis preventive therapy (TPT) with 9 months of daily isoniazid (9H)
Other Names:
  • 9H

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain-Derived Neurotrophic Factor
Time Frame: 9 months
Biomarker
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: I-Te Lee, Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2018

Primary Completion (Actual)

April 30, 2024

Study Completion (Estimated)

April 18, 2025

Study Registration Dates

First Submitted

March 8, 2025

First Submitted That Met QC Criteria

March 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCVGH-CE18090B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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