ISRCTN92545532
Completed
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 sites55 target enrollmentMay 11, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospitals Bristol NHS Foundation Trust (UK)
- Enrollment
- 55
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33681737/ (added 09/03/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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,
Outcomes
Primary Outcomes
Not specified
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