NCT Number: NCT02106039
Pulmonary Tuberculosis Patients With Diabetes Mellitus
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Faculty of Medicine, Universitas Padjadjaran, Bandung, West Java, Indonesia
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Better diabetes control in diabetes patients with tuberculosis under treatment
Time frame: 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 outcomes
-
Cost-effectiveness of different strategies for diabetes management during TB treatment
Time frame: 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
Time frame: 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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Universitas Padjadjaran
Other
Collaborators
- Leiden University Medical Center
- London School of Hygiene and Tropical Medicine
- Radboud University Medical Center
- St George's, University of London
- Universidad Peruana Cayetano Heredia
- University Medical Center Groningen
- University of Medicine and Pharmacy Craiova
- University of Otago
- University of Stellenbosch
Registry information
Official study title
Concurrent Tuberculosis and Diabetes: Clinical Monitoring, and Microbiological and Immunological Effects of Diabetes During Tuberculosis Treatment
Acronym: TANDEM
Important dates
- Study start
- 2014
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Apr 7, 2014
- Registry last updated
- Apr 18, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Prevalence of Chronic Kidney Disease (CKD) and Risk Factors in Sub-Saharan Africa
NCT03458338
Actinomycetales Infections, Bacterial Infections
Basel, Switzerland
View Trial DetailsComparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho
NCT01459120
Acquired Immunodeficiency Syndrome, Actinomycetales Infections
Seboche, Botha-Bothe, Lesotho
View Trial DetailsScalable Public Health Empowerment, Research, and Education Sites (SPHERES)
NCT07126041
Actinomycetales Infections, Bacterial Infections
Purbalingga, Central Java, Indonesia
View Trial DetailsDiabetes Prevention Program Outcomes Study
NCT00038727
Body Weight, CVD
Rockville, Maryland, United States
View Trial Details