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临床试验/EUCTR2008-002336-15-GB
EUCTR2008-002336-15-GB进行中(未招募)1 期

The effect of prednisolone versus hydrocortisone as glucocorticoid replacement therapy on hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency: a pilot study. - Hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency.

King's College London0 个研究点目标入组 3 人开始时间: 2011年5月25日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
3

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • 1. Able to provide informed consent to participate in the study
  • 2. Age 18 or over
  • 3. Type 1 diabetes.
  • 4. On current insulin regimen for at least 4 weeks.
  • 5. Understanding of the principles of self-adjustment of insulin regimen on the basis of self blood glucose monitoring results.
  • 6. Adrenal insufficiency
  • 7. On current hydrocortisone regimen for at least 2 months.
  • 8. Normal thyroid function or on appropriate thyroxine replacement.
  • 9. With or without problematic hypoglycaemia.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 16
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 16

排除标准

  • 1. Inability to give informed consent
  • 2. Age less than 18 years
  • 3. Pregnancy or breastfeeding
  • 4. Currently enrolled in other clinical study
  • 5. Islet transplant / pancreatic transplant
  • 6. Other steroid treatment (except inhalers and topical steroids)
  • 7. Unstable angina, myocardial infarction, uncontrolled congestive cardiac failure in the previous year
  • 8. Recent history of cancer (<5years)
  • 9. Chronic kidney disease ( stage 3-5)
  • 10. Liver function tests more than 3 times the upper limit of normal.
  • 11. Coagulopathy (INR>1.5 or platelets less than 50x109/L)
  • 12. Anaemia (Hb less than 10g/dL, except stable haemoglobinopathy)

研究者

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