Clinical trial NCT02106039: Pulmonary Tuberculosis Patients With Diabetes Mellitus
Official title: Concurrent Tuberculosis and Diabetes: Clinical Monitoring, and Microbiological and Immunological Effects of Diabetes During Tuberculosis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Pulmonary Tuberculosis
Keywords: diabetes mellitus
tuberculosis
management
randomized controlled trial
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Radboud University Medical Center
name: Leiden University Medical Center
name: University of Stellenbosch
name: St George's, University of London
name: University of Otago
name: University of Medicine and Pharmacy Craiova
name: University Medical Center Groningen
name: Universidad Peruana Cayetano Heredia
First posted: 2014-04-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Better diabetes control in diabetes patients with tuberculosis under treatment
timeFrame: Up to 6 months during TB treatment
Secondary outcomes:
measure: Cost-effectiveness of different strategies for diabetes management during TB treatment
timeFrame: Up to 6 months
measure: Measurement of long-term requirements for diabetes management in TB patients diagnosed with diabetes after TB treatment completed
timeFrame: 12 months after completing TB treatment
measure: Association between glycemic control and clinical-microbiological response to TB treatment
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Faculty of Medicine, Universitas Padjadjaran
state: West Java
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
state: San Martin De Porres
city: Bucharest
country: Romania
facility: University of Medicine and Pharmacy Craiova
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Hazel Dockrell, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud Universisty Nijmegen Medical Center
name: Reinout van Crevel, MD, PhD
role: STUDY_DIRECTOR
References:
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