Pulmonary Tuberculosis Patients With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— TANDEM  

Official title:

Concurrent Tuberculosis and Diabetes: Clinical Monitoring, and Microbiological and Immunological Effects of Diabetes During Tuberculosis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106039
• Other study ID #: TB-201403.01
• Status: Completed
• Phase: N/A
• Start date: April 28, 2014
• Est. completion date: December 21, 2017

Study information

• Verified date: September 2017
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 21, 2017
• Est. primary completion date: February 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Procedure:
• intensive monitoring

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Universitas Padjadjaran	Bandung	West Java
Peru	Universidad Peruana Cayetano Heredia	Lima	San Martin De Porres
Romania	University of Medicine and Pharmacy Craiova	Bucharest

Sponsors (10)

Lead Sponsor	Collaborator
Universitas Padjadjaran	Leiden University Medical Center, London School of Hygiene and Tropical Medicine, Radboud University, 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

Countries where clinical trial is conducted

Indonesia,  Peru,  Romania, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Better diabetes control in diabetes patients with tuberculosis under treatment	Diabetes control is determined by HbA1c level (unit: %) which will be measured at month 3 and 6 of TB treatment.	Up to 6 months during TB treatment
Secondary	Cost-effectiveness of different strategies for diabetes management during TB treatment	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)	Up to 6 months
Secondary	Measurement of long-term requirements for diabetes management in TB patients diagnosed with diabetes after TB treatment completed	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.	12 months after completing TB treatment
Secondary	Association between glycemic control and clinical-microbiological response to TB treatment	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.	up to 6 months

External Links

•   official website of TANDEM project