Trials / Completed
CompletedNCT02106039
Pulmonary Tuberculosis Patients With Diabetes Mellitus
Concurrent Tuberculosis and Diabetes: Clinical Monitoring, and Microbiological and Immunological Effects of Diabetes During Tuberculosis Treatment
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 350 (actual)
- Sponsor
- Universitas Padjadjaran · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | intensive monitoring |
Timeline
- Start date
- 2014-04-28
- Primary completion
- 2017-02-21
- Completion
- 2017-12-21
- First posted
- 2014-04-07
- Last updated
- 2019-04-18
Locations
3 sites across 3 countries: Indonesia, Peru, Romania
Source: ClinicalTrials.gov record NCT02106039. Inclusion in this directory is not an endorsement.