TANDEM: Pulmonary Tuberculosis Patients With Diabetes Mellitus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: intensive monitoring more intensive monitoring strategy of blood glucose and clinical review |
Procedure: intensive monitoring
|
| No Intervention: standard monitoring glucose monitoring followed the prevailing practice at each site |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine, Universitas Padjadjaran | Bandung | West Java | Indonesia | 40161 |
| 2 | Universidad Peruana Cayetano Heredia | Lima | San Martin De Porres | Peru | 31 |
| 3 | University of Medicine and Pharmacy Craiova | Bucharest | Romania |
Sponsors and Collaborators
- Universitas Padjadjaran
- 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
Investigators
- Principal Investigator: Hazel Dockrell, Prof, LSHTM
- Study Director: Reinout van Crevel, MD, PhD, Radboud Universisty Nijmegen Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Baker MA, Harries AD, Jeon CY, Hart JE, Kapur A, Lönnroth K, Ottmani SE, Goonesekera SD, Murray MB. The impact of diabetes on tuberculosis treatment outcomes: a systematic review. BMC Med. 2011 Jul 1;9:81. doi: 10.1186/1741-7015-9-81.
- Bidstrup TB, Stilling N, Damkier P, Scharling B, Thomsen MS, Brøsen K. Rifampicin seems to act as both an inducer and an inhibitor of the metabolism of repaglinide. Eur J Clin Pharmacol. 2004 Apr;60(2):109-14. Epub 2004 Mar 19.
- Hatorp V, Hansen KT, Thomsen MS. Influence of drugs interacting with CYP3A4 on the pharmacokinetics, pharmacodynamics, and safety of the prandial glucose regulator repaglinide. J Clin Pharmacol. 2003 Jun;43(6):649-60.
- Jaakkola T, Backman JT, Neuvonen M, Laitila J, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics of pioglitazone. Br J Clin Pharmacol. 2006 Jan;61(1):70-8.
- Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivistö KT. Effects of rifampin on the pharmacokinetics and pharmacodynamics of glyburide and glipizide. Clin Pharmacol Ther. 2001 Jun;69(6):400-6.
- Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivistö KT. Rifampin decreases the plasma concentrations and effects of repaglinide. Clin Pharmacol Ther. 2000 Nov;68(5):495-500.
- Niemi M, Backman JT, Neuvonen M, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of nateglinide in healthy subjects. Br J Clin Pharmacol. 2003 Oct;56(4):427-32.
- Niemi M, Kivistö KT, Backman JT, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of glimepiride. Br J Clin Pharmacol. 2000 Dec;50(6):591-5.
- Park JY, Kim KA, Kang MH, Kim SL, Shin JG. Effect of rifampin on the pharmacokinetics of rosiglitazone in healthy subjects. Clin Pharmacol Ther. 2004 Mar;75(3):157-62.
- Park JY, Kim KA, Park PW, Park CW, Shin JG. Effect of rifampin on the pharmacokinetics and pharmacodynamics of gliclazide. Clin Pharmacol Ther. 2003 Oct;74(4):334-40.
- Ruslami R, Aarnoutse RE, Alisjahbana B, van der Ven AJ, van Crevel R. Implications of the global increase of diabetes for tuberculosis control and patient care. Trop Med Int Health. 2010 Nov;15(11):1289-99. doi: 10.1111/j.1365-3156.2010.02625.x. Review.
- Syvälahti E, Pihlajamäki K, Iisalo E. Effect of tuberculostatic agents on the response of serum growth hormone and immunoreactive insulin to intravenous tolbutamide, and on the half-life of tolbutamide. Int J Clin Pharmacol Biopharm. 1976 Mar;13(2):83-9.
- Zilly W, Breimer DD, Richter E. Induction of drug metabolism in man after rifampicin treatment measured by increased hexobarbital and tolbutamide clearance. Eur J Clin Pharmacol. 1975 Dec 19;9(2-3):219-27.
- TB-201403.01