Pulmonary Tuberculosis Patients With Diabetes Mellitus

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
intensive monitoring	intensive monitoring	more intensive monitoring strategy of blood glucose and clinical review

Primary Outcome Measures

Name	Time	Method
Better diabetes control in diabetes patients with tuberculosis under treatment	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 Outcome Measures

Name	Time	Method
Association between glycemic control and clinical-microbiological response to TB treatment	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.
Cost-effectiveness of different strategies for diabetes management during TB treatment	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)
Measurement of long-term requirements for diabetes management in TB patients diagnosed with diabetes after TB treatment completed	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.

Locations (3): Faculty of Medicine, Universitas Padjadjaran
🇮🇩
Bandung, West Java, Indonesia
Universidad Peruana Cayetano Heredia
🇵🇪
Lima, San Martin De Porres, Peru
University of Medicine and Pharmacy Craiova
🇷🇴
Bucharest, Romania