Observational Cohort Study on Difference in Glucocorticoid-induced Adrenal Insufficiency in Patients With Rheumatoid Arthritis Related to Different Sensitivity Polymorphisms in the Glucocorticoid Receptor Gene
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- adrenal insufficiency
研究概览
简要总结
Development of glucocorticoid (GC)-induced adrenal insufficiency is a serious adverse effect of GC treatment. It is today not possible to predict this adverse effect. The project aims at investigating a possible individual aspect, which may render subjects more or less sensitive to glucocorticoids, and thereby influence development of GC induced adrenal insufficiency. The hypothesis is that subjects with one or another of the polymorphisms in the GC receptor gene will either have increased or diminished GC sensitivity. This may be responsible for differences in development of GC induced adrenal insufficiency.
详细描述
Blood is sampled from patients with rheumatoid arthritis (RA), fulfilling the inclusion criteria and patients are genotyped for the SNPs N363S, BclI, ER22/23EK and 9β and grouped according to haplotypes. SNPs will be determined by polymerase chain reaction (PCR). Patients will be included for a Synacthen test, to evaluate their adrenal function. Information from the results of the study will be able to assist clinicians to identify patients at risk and thus individualize GC therapy in a tailored fashion. Results of the study will be important for all patient groups worldwide on GC therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 rheumatoid arthritis.
- •1987 ACR-classification criteria.
- •Prednisolone min 5mg/day for at least 6 months.
- •Presence of either BclI (high GC sensitivity) or 9β (low GC sensitivity)polymorphisms, or wildtype for for all 4 SNPs studied. Patients with or without these polymorphisms were invited to a Synacthen® test, but patients with a mixed hetero- and homozygote genotype were not
排除标准
- •Other major organ disease
- •Females pregnant
- •Females not willing to pause estrogen-containing medications 6 weeks prior to Synacthen® test
- •unable to give a written informed content
结局指标
主要结局
adrenal insufficiency
时间窗: upon first visit within average 1 month
test for adrenal function by stimulation test (Synacthen test)
次要结局
- quality of life(upon inclusion (baseline))
- Bone Density status(results from latest DXA scan performed in routine settings, bonemarkers upon inclusion (baseline))
- body composition(upon inclusion (baselline))
- metabolic syndrome(upon inclusion (baseline))
研究者
Ulla Feldt-Rasmussen
Professor
Rigshospitalet, Denmark