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临床试验/NCT02106039
NCT02106039已完成不适用

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

Universitas Padjadjaran5 个研究点 分布在 3 个国家目标入组 350 人开始时间: 2014年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
5
主要终点
Better diabetes control in diabetes patients with tuberculosis under treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult (> 18 years old) diabetes mellitus patients
  • diagnosed as having active pulmonary TB
  • willing to join the study

排除标准

  • under TB treatment more than 72 hours
  • steroid-induced or gestational diabetes

研究组 & 干预措施

intensive monitoring

Experimental

more intensive monitoring strategy of blood glucose and clinical review

干预措施: intensive monitoring (Procedure)

standard monitoring

No Intervention

glucose monitoring followed the prevailing practice at each site

结局指标

主要结局

Better diabetes control in diabetes patients with tuberculosis under treatment

时间窗: 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.

次要结局

  • Association between glycemic control and clinical-microbiological response to TB treatment(up to 6 months)
  • Cost-effectiveness of different strategies for diabetes management during TB treatment(Up to 6 months)
  • Measurement of long-term requirements for diabetes management in TB patients diagnosed with diabetes after TB treatment completed(12 months after completing TB treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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