To evaluate the incidence of new onset diabetes in acute coronary syndrome patients on statins and evaluate the dose related risk.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Rohit Walia
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 1. Incidence of new onset diabetes at 6 months with maximum dose of statin
研究概览
简要总结
Statins have been linked to new onset diabetes. No randomised control trail is there to prove definite causation. We plan to study acute coronary syndrome patients who receive high dose statins and look at blood sugar and insulin resistance to determine their effect on inducing new onset diabetes. We study different statins : atorvastatin , simvastatin , rosuvastatin . pitavastatin , parvastatin to see which has highest effect on inducing new onset diabetes. The study participants are encouraged to maintain healthy diet and body weight over duration of study. After 6 months of intensive high dose statin the dose of statin will be reduced to minimal required and participants followed up over next 6 months. The change in blood sugar levels from baseline to highest dose of statin at 6 month and minimal dose of statin at 1 year of start of study will be assessed. Incidence of new onset diabetes and cardiovascular events will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •65 years Acute Coronary Syndrome patients Non diabetic.
排除标准
- •Diabetes Already taking lipid lowering drugs or hypoglycaemic drugs Hypo or hyperthyroid disorders Advanced Malignancy Advanced Heart Failure Taking steroids Renal failure Any chronic infection Genetic Hypercholestrolemic disorders.
结局指标
主要结局
1. Incidence of new onset diabetes at 6 months with maximum dose of statin
时间窗: 1. Incidence of new onset diabetes at 6 months with maximum dose of statin
次要结局
- Degree of change in FBG , PPBG , HbA1c from baseline to 6 months on maximum dose of statin
- Degree of change in FBG , PPBG , HbA1c after 6 months from maximum to minimum dose.(at 1 year of study drug initiation)
- Cardiovascular Events during follow up over 1 year and difference between intensive and low intensity phase.(1 year)
