Pulmonary Tuberculosis Patients With Diabetes Mellitus (TANDEM)

Universitas Padjadjaran

Status: Completed

Conditions: Pulmonary Tuberculosis; Diabetes Mellitus

Treatments: Procedure: intensive monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02106039

TB-201403.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

intensive monitoring

Experimental group

Description:

more intensive monitoring strategy of blood glucose and clinical review

Treatment:

Procedure: intensive monitoring

standard monitoring

No Intervention group

Description:

glucose monitoring followed the prevailing practice at each site