Pulmonary Tuberculosis Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Pulmonary Tuberculosis

Intervention / Treatment
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* Procedure: intensive monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intensive monitoring<br>more intensive monitoring strategy of blood glucose and clinical review | Procedure: intensive monitoring<br> <br> |
| No Intervention: standard monitoring<br>glucose monitoring followed the prevailing practice at each site | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Better diabetes control in diabetes patients with tuberculosis under treatment | Diabetes control is determined by HbA1c level (unit: %) which will be measured at month 3 and 6 of TB treatment. | Up to 6 months during TB treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of different strategies for diabetes management during TB treatment | 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) | Up to 6 months | 
| Measurement of long-term requirements for diabetes management in TB patients diagnosed with diabetes after TB treatment completed | 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. | 12 months after completing TB treatment | 
| Association between glycemic control and clinical-microbiological response to TB treatment | 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. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, tuberculosis, management, randomized controlled trial