The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Secondary Adrenal insufficiency
研究概览
简要总结
To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD.
详细描述
COPD patients who have received systemic glucocorticoid exceeding the equivalent of 180 mg prednisolone which are homo / heterozygous for the BclI and / or N363S polymorphisms (associated with increased glucocorticoid sensitivity) will have a lower cortisol response in a synacthen® test (greater suppression of adrenal corticosteroid) than the corresponding patients there are wild-type or homo- or heterozygous for the polymorphic ER22 / 23EK and / or 9β (associated with decreased sensitivity). Information from the results of the investigation will be able to help clinicians to identify patients with acute exacerbation of COPD (AECOPD) at risk of of secondary adrenal insufficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients > 18 years
- •Caucasian classified with COPD
- •Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg)
排除标准
- •Treated with estrogen-containing medications, including anticonceptiva 6 weeks prior to Synacthen®
- •Pregnancy or lactation
- •on regular systemic glucocorticoid therapy before admission to the hospital
- •People who are detained under the act on the use of coercion in psychiatry
- •Severe language problems or inability to provide written informed consent
结局指标
主要结局
Secondary Adrenal insufficiency
时间窗: average 1 month
test for adrenal function by stimulation test
次要结局
- Metabolic syndrome(average 1 month)
- Bone mineral loss(average 1 month)
- Onset of Diabetes Mellitus(average 1 month)
- Quality of life(average 1 month)
研究者
Pradeesh Sivapalan
MD, Phd fellow
Chronic Obstructive Pulmonary Disease Trial Network, Denmark