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

Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz

Sponsors

Lead sponsor: Instituto Nacional de Salud Publica, Mexico

Collaborator: National Council of Science and Technology, Mexico

Source Instituto Nacional de Salud Publica, Mexico
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.

Overall Status Withdrawn
Start Date September 20, 2017
Completion Date December 2020
Primary Completion Date May 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Treatment success Up to 6 months
Blood glucose control Up to 6 months
Condition
Intervention

Intervention type: Behavioral

Intervention name: Community intervention

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

Arm group label: Intervention

Intervention type: Drug

Intervention name: Standard of care

Description: DOTS plus standard DM2 care

Arm group label: Control

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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Duadalupe Delgado Sanchez, PhD Principal Investigator Instituto Nacional de Salud Pública
Location
facility Centro de Salud Camerino Mendoza
Location Countries

Mexico

Verification Date

May 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Instituto Nacional de Salud Publica, Mexico

Investigator full name: Guadalupe Delgado Sanchez

Investigator title: Level I National Researchers System

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control

Arm group type: Active Comparator

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

Arm group label: Intervention

Arm group type: Experimental

Description: This arm will receive the community intervention

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov