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Clinical Trials/ISRCTN92545532
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)

Registry
who.int
Start Date
May 11, 2011
End Date
August 31, 2014
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospitals Bristol NHS Foundation Trust (UK)

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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