<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03277742</url>
  </required_header>
  <id_info>
    <org_study_id>CI 1422</org_study_id>
    <nct_id>NCT03277742</nct_id>
  </id_info>
  <brief_title>Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz</brief_title>
  <official_title>Evaluation of an Integral Strategy for Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Salud Publica, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Council of Science and Technology, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Salud Publica, Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate an integral strategy in which diabetes mellitus 2&#xD;
      (DM2) and pulmonary tuberculosis (TB) are managed together. The researchers propose a&#xD;
      community intervention with two arms in 4 health centers in Orizaba, Veracruz. Patients will&#xD;
      be assigned to either arm by convenience. One arm will receive the joint treatment strategy&#xD;
      and another the routine treatment used in health services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Mexico DM2 is the main complication of patients with TB (22.2%), more so than HIV,&#xD;
      malnutrition and chronic pulmonary obstructive disease (COPD).&#xD;
&#xD;
      The World Health Organization (WHO) has proposed a framework for the joint management of TB&#xD;
      and DM2 and one of the key points is the need for studies that evaluate the viability and&#xD;
      efficacy of programs that manage both diseases jointly. There are social and clinical&#xD;
      determinants that are associated to a higher mortality in patients with DM2 and TB such as&#xD;
      poor glucose level control (glycosylated hemoglobin &gt;7mg/dl) and immunosuppression which in&#xD;
      turn increases the risk of developing a recurrent episode of TB, being multi drug resistant&#xD;
      (MDR) and/or failing TB treatment. The determinants associated to TB are the lack of&#xD;
      awareness of the disease, drug toxicity and interaction with DM2 medication and treatment&#xD;
      default. Social determinants are low income level, living in a crowded household, living in&#xD;
      rural areas, not having access to health care, having been in prison and living with people&#xD;
      with TB.&#xD;
&#xD;
      The strategy consists of interventions on patients, health personnel, community health&#xD;
      workers and directors of health services. Researchers will train patients in the use of&#xD;
      glucometers, health personnel in management of comorbidities of DM2 and TB, health workers in&#xD;
      how to support patients and increase treatment adherence. Bidirectional screening in patients&#xD;
      with TB or DM2 using bacilloscopies and glycosylated hemoglobin (HbA1c). During the 6 months&#xD;
      of directly observed treatment (DOTS) study nurses will monitor levels of glucose weekly with&#xD;
      capillary glucose, monthly with fasting glucose, in months 1, 3 and 6 with HbA1c. Patients&#xD;
      with high glucose levels will be referred to metabolic control which will be assessed by&#xD;
      experts. Regarding DOTs, first line TB drugs will be available and study nurses will&#xD;
      supervise that they are taken correctly. A nutritionist will carry out home visits to guide&#xD;
      dietary intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to safety reasons. The region was considered too dangerous.&#xD;
  </why_stopped>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment success</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Bacteriological cure using sputum smear and culture</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose control</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>mg/dl</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pulmonary Tuberculosis</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will receive the standard of care for patients with TB and DM2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive the community intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community intervention</intervention_name>
    <description>Training of patients, health personnel and community health workers. Bidirectional screening. Monitoring blood glucose levels. Home visits. Medical referral. DOTS.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>DOTS plus standard DM2 care</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of active PTB, Diagnosis of DM2, Not having started TB treatment, Attend a&#xD;
             selected health clinic, Sign a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide information, Pregnancy, HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Duadalupe Delgado Sanchez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Salud Pública</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Salud Camerino Mendoza</name>
      <address>
        <city>Orizaba</city>
        <state>Veracruz</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Martinez-Aguilar G, Serrano CJ, Castaneda-Delgado JE, Macias-Segura N, Hernandez-Delgadillo N, Enciso-Moreno L, Garcia de Lira Y, Valenzuela-Mendez E, Gandara-Jasso B, Correa-Chacon J, Bastian-Hernandez Y, Rodriguez-Moran 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.</citation>
    <PMID>25864989</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25194887</PMID>
  </reference>
  <reference>
    <citation>Delgado-Sanchez G, Garcia-Garcia L, Castellanos-Joya M, Cruz-Hervert P, Ferreyra-Reyes L, Ferreira-Guerrero E, Hernandez A, Ortega-Baeza VM, Montero-Campos R, Sulca JA, Martinez-Olivares Mde L, Mongua-Rodriguez N, Baez-Saldana R, Gonzalez-Roldan JF, Lopez-Gatell H, Ponce-de-Leon A, Sifuentes-Osornio J, Jimenez-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.</citation>
    <PMID>26075393</PMID>
  </reference>
  <reference>
    <citation>Ait-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].</citation>
    <PMID>16466046</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>May 13, 2020</last_update_submitted>
  <last_update_submitted_qc>May 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Salud Publica, Mexico</investigator_affiliation>
    <investigator_full_name>Guadalupe Delgado Sanchez</investigator_full_name>
    <investigator_title>Level I National Researchers System</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03277742
org study id: CI 1422
nct id: NCT03277742
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment success
time frame: Up to 6 months
description: Bacteriological cure using sputum smear and culture
measure: Blood glucose control
time frame: Up to 6 months
description: mg/dl
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
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
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Duadalupe Delgado Sanchez, PhD
role: Principal Investigator
affiliation: Instituto Nacional de Salud Pública
facility: 
country: Mexico
citation: Martinez-Aguilar G, Serrano CJ, Castaneda-Delgado JE, Macias-Segura N, Hernandez-Delgadillo N, Enciso-Moreno L, Garcia de Lira Y, Valenzuela-Mendez E, Gandara-Jasso B, Correa-Chacon J, Bastian-Hernandez Y, Rodriguez-Moran 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.
PMID: 25864989
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.
PMID: 25194887
citation: Delgado-Sanchez G, Garcia-Garcia L, Castellanos-Joya M, Cruz-Hervert P, Ferreyra-Reyes L, Ferreira-Guerrero E, Hernandez A, Ortega-Baeza VM, Montero-Campos R, Sulca JA, Martinez-Olivares Mde L, Mongua-Rodriguez N, Baez-Saldana R, Gonzalez-Roldan JF, Lopez-Gatell H, Ponce-de-Leon A, Sifuentes-Osornio J, Jimenez-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.
PMID: 26075393
citation: Ait-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].
PMID: 16466046
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
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No