Latent Tuberculosis in Type 2 Diabetes | NCT06874725

Studies
Latent Tuberculosis in Type 2 Diabetes

NCT06874725

Sponsor

Taichung Veterans General Hospital

Status

Active, not recruiting

Last Update Posted

Mar 13, 2025Actual

Enrollment

552Actual

Phase

Phase 4

Conditions

Latent Tuberculosis Infection

Interventions

Rifapentine and Isoniazid for 3 months
Isoniazid (INH) daily for 9 months

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2018Actual

Primary Completion Date

Apr 30, 2024Actual

Completion Date

Apr 18, 2025Estimated

First Submitted Date

Mar 8, 2025

First Submission Date that Met QC Criteria

Mar 8, 2025

First Posted Date

Mar 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2025

Last Update Posted Date

Mar 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

552Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3 months of weekly rifapentine plus isoniazid	Active Comparator	3 months of weekly rifapentine plus isoniazid	Drug: Rifapentine and Isoniazid for 3 months
9 months of daily isoniazid	Active Comparator	9 months of daily isoniazid	Drug: Isoniazid (INH) daily for 9 months

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifapentine and Isoniazid for 3 months	Drug	tuberculosis preventive therapy (TPT) with 3 months of weekly rifapentine plus isoniazid (3HP)	3 months of weekly rifapentine plus isoniazid

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
I-Te Lee	Taichung Veterans General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital		Taichung		407219	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055985	Latent Tuberculosis
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D014376	Tuberculosis
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C018421	rifapentine
D007538	Isoniazid

Ancestor Terms

ID	Term
D006834	Hydrazines
D009930	Organic Chemicals
D007539	Isonicotinic Acids
D000147	Acids, Heterocyclic

Browse Leaves

Not provided

Browse Branches

Not provided