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Completed

NCT Number: NCT02106039

Pulmonary Tuberculosis Patients With Diabetes Mellitus

The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis- diabetes patients.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Universitas Padjadjaran, Bandung, West Java, Indonesia

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About this study

Tight glycemic control may improve tuberculosis (TB) treatment outcome and help reduce symptoms. However, active TB and TB treatment hamper glycemic control. Patients starting TB treatment experience rapid changes in appetite, body composition, and inflammation (which increases insulin resistance); inflammation is a feature of untreated TB and following an increase as a result of initial bacterial killing, inflammation subsides with successful treatment. In addition, TB medication (rifampicin) increases the metabolism of oral anti-diabetic drugs including the widely used sulphonylureas and thiazolidinediones, though a possible interaction with the antidiabetic drug metformin has not been previously examined. Frequent monitoring of blood glucose with adjustments in anti-diabetes medication during the course of TB treatment may therefore be needed. However, frequent monitoring is associated with additional costs, and tools and skills for glucose monitoring and diabetes treatment may be lacking in TB or pulmonary clinics, creating a need to refer patients to other health providers. As such, a less intense schedule, preferably following the established decision points in TB treatment after 2 and 6 months would offer significant advantage. None of these issues have been addressed systematically so far.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult (> 18 years old) diabetes mellitus patients
  • diagnosed as having active pulmonary TB
  • willing to join the study

Exclusion criteria

  • under TB treatment more than 72 hours
  • steroid-induced or gestational diabetes

Treatment and study plan

intensive monitoring

Procedure

Primary outcomes

  1. Better diabetes control in diabetes patients with tuberculosis under treatment

    Time frame: Up to 6 months during TB treatment

    Diabetes control is determined by HbA1c level (unit: %) which will be measured at month 3 and 6 of TB treatment.

Secondary outcomes

  1. Cost-effectiveness of different strategies for diabetes management during TB treatment

    Time frame: Up to 6 months

    Cost analysis will include all cost for lab analysis, transportation for follow up visit, expenses for medications, all complications caused by uncontrolled diabetes (including hospitalization, medications for co morbidities)

  2. Measurement of long-term requirements for diabetes management in TB patients diagnosed with diabetes after TB treatment completed

    Time frame: 12 months after completing TB treatment

    Clinical characteristics (i.e. blood pressure, glucose control, kidney function, quality of life (QoL) of diabetes mellitus patients with TB after completing TB treatment will be measured and will be compared between both groups.

  3. Association between glycemic control and clinical-microbiological response to TB treatment

    Time frame: up to 6 months

    Association between glycemic control and clinical response to TB treatment will be determined by measuring: increasing of body weight, symptoms relieve, treatment outcome (cured, completed, failure and default), and will be compared between groups.

    Association between glycemic control and microbiological response to TB treatment will be determined by measuring sputum conversion time (time to negative culture), and will be compared between groups.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Collaborators

  • Leiden University Medical Center
  • London School of Hygiene and Tropical Medicine
  • Radboud University Medical Center
  • St George's, University of London
  • Universidad Peruana Cayetano Heredia
  • University Medical Center Groningen
  • University of Medicine and Pharmacy Craiova
  • University of Otago
  • University of Stellenbosch

Registry information

Official study title

Concurrent Tuberculosis and Diabetes: Clinical Monitoring, and Microbiological and Immunological Effects of Diabetes During Tuberculosis Treatment

Acronym: TANDEM

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2014
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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