Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of an Integral Strategy for Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03277742
• Other study ID #: CI 1422
• Status: Withdrawn
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Instituto Nacional de Salud Publica, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Behavioral:
• Community intervention
Training of patients, health personnel and community health workers. Bidirectional screening. Monitoring blood glucose levels. Home visits. Medical referral. DOTS.

Drug:
• Standard of care
DOTS plus standard DM2 care

Locations

Country	Name	City	State
Mexico	Centro de Salud Camerino Mendoza	Orizaba	Veracruz

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Salud Publica, Mexico	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Aït-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]. — View Citation

Delgado-Sánchez G, García-García L, Castellanos-Joya M, Cruz-Hervert P, Ferreyra-Reyes L, Ferreira-Guerrero E, Hernández A, Ortega-Baeza VM, Montero-Campos R, Sulca JA, Martínez-Olivares Mde L, Mongua-Rodríguez N, Baez-Saldaña R, González-Roldán JF, López-Gatell H, Ponce-de-León A, Sifuentes-Osornio J, Jiménez-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. — View Citation

Martínez-Aguilar G, Serrano CJ, Castañeda-Delgado JE, Macías-Segura N, Hernández-Delgadillo N, Enciso-Moreno L, García de Lira Y, Valenzuela-Méndez E, Gándara-Jasso B, Correa-Chacón J, Bastián-Hernández Y, Rodríguez-Morán 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success	Bacteriological cure using sputum smear and culture	Up to 6 months
Primary	Blood glucose control	mg/dl	Up to 6 months