NCT05716607撤回不适用
Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone
Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- glycemic variability
研究概览
简要总结
The aim of INS.CORT trial is, by studying glycemic variability in a well-defined patient group with both insulin & hydrocortisone (patients with concomitant insulin-treated diabetes & Addison's disease) and collecting information about the administration -time point and doses- of insulin, hydrocortisone and food intake with the help of new technology to improve the treatment in all patients treated with both insulin & glucocorticoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at age 18 to 70 years, with BMI 18-32 kg/m2 and well-defined both insulin-treated diabetes & Addison's disease for >12 months each, on insulin treatment and stable hydrocortisone replacement with once-daily dual-release hydrocortisone (20-30 mg/day) for >3 months.
排除标准
- •Any medication with other glucose lowering agents than insulin
- •Any additional underlying or intercurrent disease that may need regular or periodic pharmacological treatment with glucocorticoids during the study period, including infectious diseases
- •Any medication with agents which in the investigator's judgement might interfere with the study drugs kinetics, including therapies affecting gastrointestinal emptying or motility
- •Any medication with oral estrogen supplementation and/or regular DHEA medication for the past 4 weeks
- •Clinically significant renal dysfunction with a serum creatinine above 160 mmol/L
- •Active malignancy
- •Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary/pancreatic disease which in the investigator's judgement may interfere with the study assessment
- •Pregnant or lactating women
- •Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator.
研究组 & 干预措施
Once-daily dual-release hydrocortisone
Experimental
干预措施: OD dual-release Hydrocortisone (Drug)
Thrice-daily conventional immediate-release hydrocortisone
Active Comparator
干预措施: TID Hydrocortisone (Drug)
结局指标
主要结局
glycemic variability
时间窗: 4 weeks
glycemic variability
次要结局
- SR(4 weeks)
- fibrinogen(4 weeks)
- Time below range (glucose)(4 weeks)
- Time in range (glucose)(4 weeks)
- Cortisol exposure-time profile(4 weeks)
- systolic blood pressure(4 weeks)
- diastolic blood pressure(4 weeks)
- ADDIQoL(4 weeks)
- HbA1c(4 weeks)
- Time above range (glucose)(4 weeks)
- PGWB(4 weeks)
- ADAM17(4 weeks)
- transcriptomics(4 weeks)
- microRNAs(4 weeks)
- proteomics(4 weeks)
- metabolomics(4 weeks)
- hsCRP fibrinogen, immunoglobulin(4 weeks)
- FIS(4 weeks)
- FOSQ(4 weeks)
- Fever(4 weeks)
- CD16(4 weeks)
- immunoglobulins(4 weeks)
研究者
DimitriosChantzichristos
Principal Investigator
Vastra Gotaland Region
研究点 (1)
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