Steroid induced Diabetes Mellitus in Cancer patients due to use of Dexamethasone as premedication for chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Patients who become newly detected diabetes mellitus defined as FBS more than or equal to 126 mg/dL or HbA1c more than or equal to 6.5%
研究概览
简要总结
This study is being conducted as proof of concept to use dexamethasone or other steroid free regimens in premedication of chemotherapy in cancer patients. It will be carried out in non diabetic patients to study the incidence of diabetes mellitus in patients receiving steroids a premedication of chemotherapy. It will also study the effect of steroids on insulin resistance, long term-effect of steroids on diabetes mellitus and patient reported outcomes of chemotherapy induced nausea and vomiting.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Cancer patients receiving dexamethasone as premedication for chemotherapy.
排除标准
- •Known diabetics or newly detected diabetes mellitus defined as FBS >126 mg/dL, RBS >200 mg/dL or HbA1c >6.5% at baseline testing.
结局指标
主要结局
Patients who become newly detected diabetes mellitus defined as FBS more than or equal to 126 mg/dL or HbA1c more than or equal to 6.5%
时间窗: Fasting blood glucose, Post prandial blood glucose and HbA1c will be checked at 3 months and 6 months after start of dexamethasone.
次要结局
- Fasting insulin levels will be studied & insulin resistance will be calculated by HOMA-IR formula. High insulin resistance will be defined by HOMA-IR more than or equal to 2.5.(Fasting insulin levels will be studied at baseline, before start of dexamethasone & at 3 months & 6 months after starting dexamethasone.)
- Patient reported outcome of chemotherapy induced nausea & vomiting will be recorded using the FLIE questionnaire.(The questionnaire will be administered at baseline, then at the beginning of every cycle for 6 to 8 cycles of chemotherapy as per patient treatment protocol.)
- Patients who become newly detected diabetes mellitus defined as FBS more than or equal to 126 mg/dL or HbA1c more than or equal to 6.5%(Patients who complete their treatment & remain steroid free for 6 months after completion of treatment will undergo fasting blood glucose, post prandial blood glucose, fasting insulin level & HbA1c testing at 12 months after enrollment.)
研究者
Ruhi Kumar
Stanley Medical College