COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (Due to safety reasons.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
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Guadalupe Delgado Sanchez, 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.

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Diabetes Mellitus, Type 2 Behavioral: Community intervention Drug: Standard of care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Experimental: Intervention
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.

Primary Outcome Measures :
  1. Treatment success [ Time Frame: Up to 6 months ]
    Bacteriological cure using sputum smear and culture

  2. Blood glucose control [ Time Frame: Up to 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03277742

Layout table for location information
Centro de Salud Camerino Mendoza
Orizaba, Veracruz, Mexico
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
National Council of Science and Technology, Mexico
Layout table for investigator information
Principal Investigator: Duadalupe Delgado Sanchez, PhD Instituto Nacional de Salud Pública

Layout table for additonal information
Responsible Party: Guadalupe Delgado Sanchez, Level I National Researchers System, Instituto Nacional de Salud Publica, Mexico Identifier: NCT03277742    
Other Study ID Numbers: CI 1422
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis, Pulmonary
Diabetes Mellitus, Type 2
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections