Latent Tuberculosis in Type 2 Diabetes

NCT ID: NCT06874725

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

552 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2025-04-18

Brief Summary

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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

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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.

Conditions

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Latent Tuberculosis Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3 months of weekly rifapentine plus isoniazid

3 months of weekly rifapentine plus isoniazid

Group Type ACTIVE_COMPARATOR

Rifapentine and Isoniazid for 3 months

Intervention Type DRUG

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

9 months of daily isoniazid

9 months of daily isoniazid

Group Type ACTIVE_COMPARATOR

Isoniazid (INH) daily for 9 months

Intervention Type DRUG

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

Interventions

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Rifapentine and Isoniazid for 3 months

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

Intervention Type DRUG

Isoniazid (INH) daily for 9 months

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

Intervention Type DRUG

Other Intervention Names

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3HP 9H

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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I-Te Lee

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TCVGH-CE18090B

Identifier Type: -

Identifier Source: org_study_id

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