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
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