The Effect of Inhaled Corticosteroids on the Risk of Diabetes, Impaired Glucose Tolerance and Characteristics of Glucose Regulation in Adults With Asthma : a Population Based Matched Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,394
- 试验地点
- 4
- 主要终点
- To investigate the ICS effect on the risk of DM/IGT/insulin resistance
研究概览
简要总结
Inhaled steroid has been the cornerstone in the treatment of asthma, which carries a huge patient population worldwide including Hong Kong. In general, the safety of long-term use of inhaled steroid has been well documented. Yet, long-term users of such treatment carry increased risk of complications like cataract. In particular, the exact association of inhaled steroid use and development of diabetes mellitus is not known, despite a clear causal relationship between oral steroid use and diabetes. Therefore this epidemiology study (based on questionnaire and blood tests) aims to investigate the effect of inhaled corticosteroid on the risk of diabetes, impaired glucose tolerance and insulin resistance in adults with asthma. The impact of this study is expected to affect the current practice of long-term use of inhaled corticosteroid especially among patients with asthma.
详细描述
Inhaled corticosteroids (ICS) have been shown to have many side effects that are consistent with systemic corticosteroids, suggesting that its systemic absorption can lead to adverse effects in the long term users. ICS can pose a major health impact in the community, especially when its use has become widely accepted as mainstay treatment for asthma and chronic obstructive airway diseases in recent decades.
In 1997, inhaled corticosteroids were shown to increase the risk of nuclear cataracts by 1.5-fold and posterior subcapsular cataracts by 1.9-fold respectively. Besides, high dose ICS use for more than 3 months increased risk of open angle glaucoma with OR 1.44. In 1998, a case control study demonstrated positive association of cataract extraction in elderly ICS users. ICS use of more than 3 years increased cataract by 3-fold in high dose users (> 1mg daily budesonide dipropionate). Whereas low dose use (<1mg daily budesonide dipropionate) for more than 2 years increased cataract by 1.6-fold. Subsequent studies also found increased risk of osteoporosis in long term ICS users.
It has been well known that systemic corticosteroid causes diabetes by inducing insulin resistance. Previous study showed a 2-fold increased risk of diabetes in patients using systemic corticosteroids.
Nevertheless, of the many systemic side effects that are known to inhaled corticosteroids, its effect on the risk of diabetes has not been established yet.
There have also been 2 small scale studies about the effect of ICS on insulin resistance profile, however, the study findings were also inconclusive.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma patients who have follow-up in our asthma clinics; OR Eligible subjects belonging to 1996 population cohort, which represents the general population ie. same base population as the asthma patients
- •Current inhaled corticosteroid users
排除标准
- •On maintenance oral steroid
- •Oral steroid use within 180 days prior to study
- •Known secondary causes for diabetes including pregnancy, cushing's syndrome and acromegaly
- •Inhaled corticosteroid use for < 6 months
- •Asthma exacerbation in recent 1 month, yet without need for systemic steroid use, as previous study has shown increased insulin resistance in subjects with unstable asthma, in relation to the acute stress during attack, which subsequently returned to normal after 1 month on disease stabilization
结局指标
主要结局
To investigate the ICS effect on the risk of DM/IGT/insulin resistance
时间窗: 1 year
次要结局
- To study the dose response relationship and effect modifying factors if risk is present(1 year)