Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz

Not Applicable

Withdrawn

• Conditions: Pulmonary Tuberculosis; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Community intervention; Drug: Standard of care

• Registration Number: NCT03277742
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Study Start: 2017-09-20
• Status Verified: 2020-05
• Primary Completion: 2020-05
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-15
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Community intervention	This arm will receive the community intervention
Control	Standard of care	This arm will receive the standard of care for patients with TB and DM2

Primary Outcome Measures

Name	Time	Method
Treatment success	Up to 6 months	Bacteriological cure using sputum smear and culture
Blood glucose control	Up to 6 months	mg/dl

Trial Locations

Locations (1)

Centro de Salud Camerino Mendoza; 🇲🇽 Orizaba, Veracruz, Mexico