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Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz

Primary Purpose

Pulmonary Tuberculosis, Diabetes Mellitus, Type 2

Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Community intervention
Standard of care
Sponsored by
Instituto Nacional de Salud Publica, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Tuberculosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of active PTB, Diagnosis of DM2, Not having started TB treatment, Attend a selected health clinic, Sign a written informed consent

Exclusion Criteria:

  • Unable to provide information, Pregnancy, HIV infection

Sites / Locations

  • Centro de Salud Camerino Mendoza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

This arm will receive the standard of care for patients with TB and DM2

This arm will receive the community intervention

Outcomes

Primary Outcome Measures

Treatment success
Bacteriological cure using sputum smear and culture
Blood glucose control
mg/dl

Secondary Outcome Measures

Full Information

First Posted
September 7, 2017
Last Updated
May 13, 2020
Sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
National Council of Science and Technology, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03277742
Brief Title
Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz
Official Title
Evaluation of an Integral Strategy for Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to safety reasons. The region was considered too dangerous.
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
National Council of Science and Technology, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate an integral strategy in which diabetes mellitus 2 (DM2) and pulmonary tuberculosis (TB) are managed together. The researchers propose a community intervention with two arms in 4 health centers in Orizaba, Veracruz. Patients will be assigned to either arm by convenience. One arm will receive the joint treatment strategy and another the routine treatment used in health services.
Detailed Description
In Mexico DM2 is the main complication of patients with TB (22.2%), more so than HIV, malnutrition and chronic pulmonary obstructive disease (COPD). The World Health Organization (WHO) has proposed a framework for the joint management of TB and DM2 and one of the key points is the need for studies that evaluate the viability and efficacy of programs that manage both diseases jointly. There are social and clinical determinants that are associated to a higher mortality in patients with DM2 and TB such as poor glucose level control (glycosylated hemoglobin >7mg/dl) and immunosuppression which in turn increases the risk of developing a recurrent episode of TB, being multi drug resistant (MDR) and/or failing TB treatment. The determinants associated to TB are the lack of awareness of the disease, drug toxicity and interaction with DM2 medication and treatment default. Social determinants are low income level, living in a crowded household, living in rural areas, not having access to health care, having been in prison and living with people with TB. The strategy consists of interventions on patients, health personnel, community health workers and directors of health services. Researchers will train patients in the use of glucometers, health personnel in management of comorbidities of DM2 and TB, health workers in how to support patients and increase treatment adherence. Bidirectional screening in patients with TB or DM2 using bacilloscopies and glycosylated hemoglobin (HbA1c). During the 6 months of directly observed treatment (DOTS) study nurses will monitor levels of glucose weekly with capillary glucose, monthly with fasting glucose, in months 1, 3 and 6 with HbA1c. Patients with high glucose levels will be referred to metabolic control which will be assessed by experts. Regarding DOTs, first line TB drugs will be available and study nurses will supervise that they are taken correctly. A nutritionist will carry out home visits to guide dietary intake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
This arm will receive the standard of care for patients with TB and DM2
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This arm will receive the community intervention
Intervention Type
Behavioral
Intervention Name(s)
Community intervention
Intervention Description
Training of patients, health personnel and community health workers. Bidirectional screening. Monitoring blood glucose levels. Home visits. Medical referral. DOTS.
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
DOTS plus standard DM2 care
Primary Outcome Measure Information:
Title
Treatment success
Description
Bacteriological cure using sputum smear and culture
Time Frame
Up to 6 months
Title
Blood glucose control
Description
mg/dl
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of active PTB, Diagnosis of DM2, Not having started TB treatment, Attend a selected health clinic, Sign a written informed consent Exclusion Criteria: Unable to provide information, Pregnancy, HIV infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duadalupe Delgado Sanchez, PhD
Organizational Affiliation
Instituto Nacional de Salud Pública
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud Camerino Mendoza
City
Orizaba
State/Province
Veracruz
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25864989
Citation
Martinez-Aguilar G, Serrano CJ, Castaneda-Delgado JE, Macias-Segura N, Hernandez-Delgadillo N, Enciso-Moreno L, Garcia de Lira Y, Valenzuela-Mendez E, Gandara-Jasso B, Correa-Chacon J, Bastian-Hernandez Y, Rodriguez-Moran M, Guerrero-Romero F, Enciso-Moreno JA. Associated Risk Factors for Latent Tuberculosis Infection in Subjects with Diabetes. Arch Med Res. 2015 Apr;46(3):221-7. doi: 10.1016/j.arcmed.2015.03.009. Epub 2015 Apr 10.
Results Reference
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PubMed Identifier
25194887
Citation
Riza AL, Pearson F, Ugarte-Gil C, Alisjahbana B, van de Vijver S, Panduru NM, Hill PC, Ruslami R, Moore D, Aarnoutse R, Critchley JA, van Crevel R. Clinical management of concurrent diabetes and tuberculosis and the implications for patient services. Lancet Diabetes Endocrinol. 2014 Sep;2(9):740-53. doi: 10.1016/S2213-8587(14)70110-X.
Results Reference
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PubMed Identifier
26075393
Citation
Delgado-Sanchez G, Garcia-Garcia L, Castellanos-Joya M, Cruz-Hervert P, Ferreyra-Reyes L, Ferreira-Guerrero E, Hernandez A, Ortega-Baeza VM, Montero-Campos R, Sulca JA, Martinez-Olivares Mde L, Mongua-Rodriguez N, Baez-Saldana R, Gonzalez-Roldan JF, Lopez-Gatell H, Ponce-de-Leon A, Sifuentes-Osornio J, Jimenez-Corona ME. Association of Pulmonary Tuberculosis and Diabetes in Mexico: Analysis of the National Tuberculosis Registry 2000-2012. PLoS One. 2015 Jun 15;10(6):e0129312. doi: 10.1371/journal.pone.0129312. eCollection 2015.
Results Reference
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PubMed Identifier
16466046
Citation
Ait-Khaled N, Enarson DA, Bencharif N, Boulahdib F, Camara LM, Dagli E, Djankine TK, Keita B, Karadag B, Ngoran K, Odhiambo J, Ottmani SE, Pham DL, Sow O, Yousser M, Zidouni N. Implementation of asthma guidelines in health centres of several developing countries. Int J Tuberc Lung Dis. 2006 Jan;10(1):104-9. Erratum In: Int J Tuberc Lung Dis. 2006 Nov;10(11):1304. Koadag, B [corrected to Karadag, B].
Results Reference
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Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz

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