Diabetes Mellitus, Pulmonary Tuberculosis
Conditions
Keywords
diabetes mellitus, tuberculosis, management, randomized controlled trial
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.
Interventions
PROCEDUREintensive monitoring
Sponsors
London School of Hygiene and Tropical Medicine
Radboud University Medical Center
Leiden University Medical Center
University of Stellenbosch
St George's, University of London
University of Otago
University of Medicine and Pharmacy Craiova
University Medical Center Groningen
Universidad Peruana Cayetano Heredia
Universitas Padjadjaran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Indonesia, Peru, Romania
Outcome results
None listed