Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz
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|ClinicalTrials.gov Identifier: NCT03277742|
Recruitment Status : Withdrawn (Due to safety reasons. The region was considered too dangerous.)
First Posted : September 11, 2017
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Tuberculosis Diabetes Mellitus, Type 2||Behavioral: Community intervention Drug: Standard of care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an Integral Strategy for Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz.|
|Actual Study Start Date :||September 20, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Control
This arm will receive the standard of care for patients with TB and DM2
Drug: Standard of care
DOTS plus standard DM2 care
This arm will receive the community intervention
Behavioral: Community intervention
Training of patients, health personnel and community health workers. Bidirectional screening. Monitoring blood glucose levels. Home visits. Medical referral. DOTS.
- Treatment success [ Time Frame: Up to 6 months ]Bacteriological cure using sputum smear and culture
- Blood glucose control [ Time Frame: Up to 6 months ]mg/dl
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277742
|Centro de Salud Camerino Mendoza|
|Orizaba, Veracruz, Mexico|
|Principal Investigator:||Duadalupe Delgado Sanchez, PhD||Instituto Nacional de Salud Pública|