A Randomized, Controlled, Multi-Centre Trial on the Effects of Dual-release Hydrocortisone Preparations Versus Conventional Glucocorticoid Replacement Therapy in Patients Affected by Primary and Secondary Adrenal Insufficiency. DREAM Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Change from baseline in measurement of weight at 3 and 6 months
研究概览
简要总结
This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.
详细描述
Hypocortisolism is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving conventional glucocorticoids therapy have compromised quality of life, reduced bone mass, increased risk factors for cardiovascular disease, infectious, tumors and premature mortality that is more than twice the mortality rate in the background population. Circulating cortisol levels follow a distinct diurnal pattern with high levels in the early morning and low trough values around midnight. Using available formulations for replacement therapy this circadian rhythm is had to mimic and also during the active time of the day high peaks and low troughs occur.
In this trial a dual-release hydrocortisone preparations that has in healthy volunteers been able to mimic the circadian pattern of circulating cortisol was studied in patients with primary and secondary adrenal insufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously diagnosed (e.g. more than 6 months ago) primary or secondary adrenal insufficiency with a stable daily glucocorticoid substitution dose for at least 3 months prior to study entry
- •Signed informed consent to participate in the study
排除标准
- •acute primary or secondary adrenal insufficiency
- •clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease
- •clinically significant renal dysfunction
- •any medication with agents which could interfere with glucocorticoid kinetics
研究组 & 干预措施
Plenadren
Plenadren (modified release hydrocortison) 20-25 or 30 mg oral tablets will be administered once-daily at 8.00 AM in the fasting state The dose is kept the same as patients had before entering the trial.
干预措施: Plenadren (Drug)
Conventional glucocorticoid therapy
Hydrocortisone (dose range 10 to 30) mg will be continued as before entering the study. Cortisone Acetate (dose 25 to 37.5 mg) will be continued as before entering the study. The morning dose will be administered in the fasting state.
The total daily dose and timing is not changed during the study period.
干预措施: Conventional glucocorticoid therapy (Drug)
结局指标
主要结局
Change from baseline in measurement of weight at 3 and 6 months
时间窗: 0, + 3 months, + 6 months
Single outcome measurement of body weight (kg).
次要结局
- Change from baseline in metabolic status at 3 and 6 months(0, + 3 months, + 6 months)
- Evaluation of immunological profile at baseline 3 and 6 months.(0, + 3 months, + 6 months)
- Evaluation of hepatic steatosis from baseline at 6 months(0, + 6 months)
- Evaluation of bone deposition and resorption markers from baseline at 6 months(0, + 6 months)
- Evaluation of epicardial fat thickness from baseline at 6 months(0, + 6 months)
- Changes in quality of life from baseline at 2, 3 and 6 months(0, + 2 months, +3 months, + 6 months)
- Bone mineral density(0, + 6 months)
研究者
Andrea M. Isidori
Professor
University of Roma La Sapienza