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临床试验/ISRCTN92545532
ISRCTN92545532已完成未知

A prospective, double-blind, randomised, parallel group, placebo-controlled trial of metformin treatment for renal angiomyolipomas in tuberous sclerosis complex

niversity Hospitals Bristol NHS Foundation Trust (UK)0 个研究点目标入组 55 人开始时间: 2011年5月11日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
55

研究概览

简要总结

2021 results in https://pubmed.ncbi.nlm.nih.gov/33681737/ (added 09/03/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Clinically definite diagnosis of TSC (modified Gomez criteria)
  • 2. Age between 10 to 65 years
  • 3. One or more renal angiomyolipoma of at least one centimetre in largest diameter
  • 4. Signed informed consent

排除标准

  • 1. Serious intercurrent illness or uncontrolled disease which could compromise
  • participation in the study
  • 2. Impairment of renal function
  • 3. Use of x-ray contrast medium containing iodine within the last 30 days
  • 4. Multiple renal angiomyolipomas where individual lesions cannot be distinguished (and
  • as such cannot be accurately measured)
  • 5. Renal haemorrhage within the preceding year
  • 6. Known conservatively managed renal aneurysm(s) greater than 10mm
  • 7. Liver insufficiency
  • 8. Acute or chronic disease which may cause tissue hypoxia e.g.cardiac/respiratory failure,
  • recent myocardial infarction, shock
  • 9. Diabetes
  • 10. Treatment with any injected or oral hypoglycaemic drug
  • 11. Use of an investigational drug within the last 30 days
  • 12. Pregnant or intending to become pregnant during the study period
  • 13. Breastfeeding

研究者

发起方
niversity Hospitals Bristol NHS Foundation Trust (UK)

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