Latent Tuberculosis in Type 2 Diabetes

Phase 4

Active, not recruiting

• Conditions: Latent Tuberculosis Infection
• Interventions: Drug: Rifapentine and Isoniazid for 3 months; Drug: Isoniazid (INH) daily for 9 months

• Registration Number: NCT06874725
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study Start: 2018-04-18
• Primary Completion: 2024-04-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-08
• Study First Submitted QC: 2025-03-08
• Last Update Submitted: 2025-03-08
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Study Completion: 2025-04-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 552

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 months of weekly rifapentine plus isoniazid	Rifapentine and Isoniazid for 3 months	3 months of weekly rifapentine plus isoniazid
9 months of daily isoniazid	Isoniazid (INH) daily for 9 months	9 months of daily isoniazid

Primary Outcome Measures

Name	Time	Method
Brain-Derived Neurotrophic Factor	9 months	Biomarker

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	9 months	aryl hydrocarbon receptor, adhesion molecules, dickkopf-related protein 1

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan